Protocol Index	

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RSH OP PRO00037917 / BR23-001 ARM 1	

Types:      Research Oncology Treatment
Synonyms:  PSYCHOTHERAPY , PALLIATIVE CARE 

Cycles 1 to 3	Repeat 3 times	Cycle length: 7 days	Day 1	Perform every 0 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.

All concomitant medications received within 28 days before the start of trial and 30 days after the last trial intervention should be recorded.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serious Adverse Events.

 All AEs from the time of trial treatment initiation through 30 days after the last trial intervention should be recorded and must be reported by the investigator. 
All SAEs from baseline through 30 days after the last trial intervention should be recorded and must be reported by the investigator. For the time period beginning when the consent form is signed until trial treatment initiation, any SAE or follow-up to a SAE including death due to any cause that occurs to any patient must be reported within 24 hours to the Sponsor ( CTOMgmt@houstonmethodist.org  and/or ORS@houstonmethodist.org) if it causes the patient to be excluded from the trial or is the result of a protocol-specified intervention.
			Supportive Care
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Spiritual care or psychotherapy/ meditation 

Spiritual care sessions with a chaplain or psychotherapy/meditation sessions with psychotherapist/ meditation instructor (per patients' choice which intervention) will be provided once per week for 24 weeks. For the chaplain-provided spiritual care, ONC-5 and the Chaplaincy Taxonomy will be utilized for intervention and assessment. Each session will be one hour. Sessions will be in-person with virtual modifications as needed. All patients will also receive  SOC and palliative measures plus chemotherapy if recommended.
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	SOC and palliative measures plus chemotherapy if recommended.
					
Cycle 4	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 0 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.

All concomitant medications received within 28 days before the start of trial and 30 days after the last trial intervention should be recorded.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serious Adverse Events.

 All AEs from the time of trial treatment initiation through 30 days after the last trial intervention should be recorded and must be reported by the investigator. 
All SAEs from baseline through 30 days after the last trial intervention should be recorded and must be reported by the investigator. For the time period beginning when the consent form is signed until trial treatment initiation, any SAE or follow-up to a SAE including death due to any cause that occurs to any patient must be reported within 24 hours to the Sponsor ( CTOMgmt@houstonmethodist.org  and/or ORS@houstonmethodist.org) if it causes the patient to be excluded from the trial or is the result of a protocol-specified intervention.
			Supportive Care
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Spiritual care or psychotherapy/ meditation 

Spiritual care sessions with a chaplain or psychotherapy/meditation sessions with psychotherapist/ meditation instructor (per patients' choice which intervention) will be provided once per week for 24 weeks. For the chaplain-provided spiritual care, ONC-5 and the Chaplaincy Taxonomy will be utilized for intervention and assessment. Each session will be one hour. Sessions will be in-person with virtual modifications as needed. All patients will also receive  SOC and palliative measures plus chemotherapy if recommended.
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	SOC and palliative measures plus chemotherapy if recommended.
			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Correlative blood collection will be performed at baseline and every 4 weeks for 24 weeks (6 blood draws). Blood will be collected into standard vacutainer tubes (3 green top tubes).
					
Cycles 5 to 7	Repeat 3 times	Cycle length: 7 days	Day 1	Perform every 0 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.

All concomitant medications received within 28 days before the start of trial and 30 days after the last trial intervention should be recorded.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serious Adverse Events.

 All AEs from the time of trial treatment initiation through 30 days after the last trial intervention should be recorded and must be reported by the investigator. 
All SAEs from baseline through 30 days after the last trial intervention should be recorded and must be reported by the investigator. For the time period beginning when the consent form is signed until trial treatment initiation, any SAE or follow-up to a SAE including death due to any cause that occurs to any patient must be reported within 24 hours to the Sponsor ( CTOMgmt@houstonmethodist.org  and/or ORS@houstonmethodist.org) if it causes the patient to be excluded from the trial or is the result of a protocol-specified intervention.
			Supportive Care
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Spiritual care or psychotherapy/ meditation 

Spiritual care sessions with a chaplain or psychotherapy/meditation sessions with psychotherapist/ meditation instructor (per patients' choice which intervention) will be provided once per week for 24 weeks. For the chaplain-provided spiritual care, ONC-5 and the Chaplaincy Taxonomy will be utilized for intervention and assessment. Each session will be one hour. Sessions will be in-person with virtual modifications as needed. All patients will also receive  SOC and palliative measures plus chemotherapy if recommended.
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	SOC and palliative measures plus chemotherapy if recommended.
					
Cycle 8	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 0 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.

All concomitant medications received within 28 days before the start of trial and 30 days after the last trial intervention should be recorded.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serious Adverse Events.

 All AEs from the time of trial treatment initiation through 30 days after the last trial intervention should be recorded and must be reported by the investigator. 
All SAEs from baseline through 30 days after the last trial intervention should be recorded and must be reported by the investigator. For the time period beginning when the consent form is signed until trial treatment initiation, any SAE or follow-up to a SAE including death due to any cause that occurs to any patient must be reported within 24 hours to the Sponsor ( CTOMgmt@houstonmethodist.org  and/or ORS@houstonmethodist.org) if it causes the patient to be excluded from the trial or is the result of a protocol-specified intervention.
			Supportive Care
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Spiritual care or psychotherapy/ meditation 

Spiritual care sessions with a chaplain or psychotherapy/meditation sessions with psychotherapist/ meditation instructor (per patients' choice which intervention) will be provided once per week for 24 weeks. For the chaplain-provided spiritual care, ONC-5 and the Chaplaincy Taxonomy will be utilized for intervention and assessment. Each session will be one hour. Sessions will be in-person with virtual modifications as needed. All patients will also receive  SOC and palliative measures plus chemotherapy if recommended.
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	SOC and palliative measures plus chemotherapy if recommended.
			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Correlative blood collection will be performed at baseline and every 4 weeks for 24 weeks (6 blood draws). Blood will be collected into standard vacutainer tubes (3 green top tubes).
					
Cycles 9 to 11	Repeat 3 times	Cycle length: 7 days	Day 1	Perform every 0 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.

All concomitant medications received within 28 days before the start of trial and 30 days after the last trial intervention should be recorded.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serious Adverse Events.

 All AEs from the time of trial treatment initiation through 30 days after the last trial intervention should be recorded and must be reported by the investigator. 
All SAEs from baseline through 30 days after the last trial intervention should be recorded and must be reported by the investigator. For the time period beginning when the consent form is signed until trial treatment initiation, any SAE or follow-up to a SAE including death due to any cause that occurs to any patient must be reported within 24 hours to the Sponsor ( CTOMgmt@houstonmethodist.org  and/or ORS@houstonmethodist.org) if it causes the patient to be excluded from the trial or is the result of a protocol-specified intervention.
			Supportive Care
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Spiritual care or psychotherapy/ meditation 

Spiritual care sessions with a chaplain or psychotherapy/meditation sessions with psychotherapist/ meditation instructor (per patients' choice which intervention) will be provided once per week for 24 weeks. For the chaplain-provided spiritual care, ONC-5 and the Chaplaincy Taxonomy will be utilized for intervention and assessment. Each session will be one hour. Sessions will be in-person with virtual modifications as needed. All patients will also receive  SOC and palliative measures plus chemotherapy if recommended.
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	SOC and palliative measures plus chemotherapy if recommended.
					
Cycle 12	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 0 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.

All concomitant medications received within 28 days before the start of trial and 30 days after the last trial intervention should be recorded.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serious Adverse Events.

 All AEs from the time of trial treatment initiation through 30 days after the last trial intervention should be recorded and must be reported by the investigator. 
All SAEs from baseline through 30 days after the last trial intervention should be recorded and must be reported by the investigator. For the time period beginning when the consent form is signed until trial treatment initiation, any SAE or follow-up to a SAE including death due to any cause that occurs to any patient must be reported within 24 hours to the Sponsor ( CTOMgmt@houstonmethodist.org  and/or ORS@houstonmethodist.org) if it causes the patient to be excluded from the trial or is the result of a protocol-specified intervention.
			Supportive Care
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Spiritual care or psychotherapy/ meditation 

Spiritual care sessions with a chaplain or psychotherapy/meditation sessions with psychotherapist/ meditation instructor (per patients' choice which intervention) will be provided once per week for 24 weeks. For the chaplain-provided spiritual care, ONC-5 and the Chaplaincy Taxonomy will be utilized for intervention and assessment. Each session will be one hour. Sessions will be in-person with virtual modifications as needed. All patients will also receive  SOC and palliative measures plus chemotherapy if recommended.
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	SOC and palliative measures plus chemotherapy if recommended.
			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Correlative blood collection will be performed at baseline and every 4 weeks for 24 weeks (6 blood draws). Blood will be collected into standard vacutainer tubes (3 green top tubes).
					
Cycles 13 to 15	Repeat 3 times	Cycle length: 7 days	Day 1	Perform every 0 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.

All concomitant medications received within 28 days before the start of trial and 30 days after the last trial intervention should be recorded.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serious Adverse Events.

 All AEs from the time of trial treatment initiation through 30 days after the last trial intervention should be recorded and must be reported by the investigator. 
All SAEs from baseline through 30 days after the last trial intervention should be recorded and must be reported by the investigator. For the time period beginning when the consent form is signed until trial treatment initiation, any SAE or follow-up to a SAE including death due to any cause that occurs to any patient must be reported within 24 hours to the Sponsor ( CTOMgmt@houstonmethodist.org  and/or ORS@houstonmethodist.org) if it causes the patient to be excluded from the trial or is the result of a protocol-specified intervention.
			Supportive Care
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Spiritual care or psychotherapy/ meditation 

Spiritual care sessions with a chaplain or psychotherapy/meditation sessions with psychotherapist/ meditation instructor (per patients' choice which intervention) will be provided once per week for 24 weeks. For the chaplain-provided spiritual care, ONC-5 and the Chaplaincy Taxonomy will be utilized for intervention and assessment. Each session will be one hour. Sessions will be in-person with virtual modifications as needed. All patients will also receive  SOC and palliative measures plus chemotherapy if recommended.
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	SOC and palliative measures plus chemotherapy if recommended.
					
Cycle 16	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 0 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.

All concomitant medications received within 28 days before the start of trial and 30 days after the last trial intervention should be recorded.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serious Adverse Events.

 All AEs from the time of trial treatment initiation through 30 days after the last trial intervention should be recorded and must be reported by the investigator. 
All SAEs from baseline through 30 days after the last trial intervention should be recorded and must be reported by the investigator. For the time period beginning when the consent form is signed until trial treatment initiation, any SAE or follow-up to a SAE including death due to any cause that occurs to any patient must be reported within 24 hours to the Sponsor ( CTOMgmt@houstonmethodist.org  and/or ORS@houstonmethodist.org) if it causes the patient to be excluded from the trial or is the result of a protocol-specified intervention.
			Supportive Care
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Spiritual care or psychotherapy/ meditation 

Spiritual care sessions with a chaplain or psychotherapy/meditation sessions with psychotherapist/ meditation instructor (per patients' choice which intervention) will be provided once per week for 24 weeks. For the chaplain-provided spiritual care, ONC-5 and the Chaplaincy Taxonomy will be utilized for intervention and assessment. Each session will be one hour. Sessions will be in-person with virtual modifications as needed. All patients will also receive  SOC and palliative measures plus chemotherapy if recommended.
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	SOC and palliative measures plus chemotherapy if recommended.
			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Correlative blood collection will be performed at baseline and every 4 weeks for 24 weeks (6 blood draws). Blood will be collected into standard vacutainer tubes (3 green top tubes).
					
Cycles 17 to 19	Repeat 3 times	Cycle length: 7 days	Day 1	Perform every 0 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.

All concomitant medications received within 28 days before the start of trial and 30 days after the last trial intervention should be recorded.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serious Adverse Events.

 All AEs from the time of trial treatment initiation through 30 days after the last trial intervention should be recorded and must be reported by the investigator. 
All SAEs from baseline through 30 days after the last trial intervention should be recorded and must be reported by the investigator. For the time period beginning when the consent form is signed until trial treatment initiation, any SAE or follow-up to a SAE including death due to any cause that occurs to any patient must be reported within 24 hours to the Sponsor ( CTOMgmt@houstonmethodist.org  and/or ORS@houstonmethodist.org) if it causes the patient to be excluded from the trial or is the result of a protocol-specified intervention.
			Supportive Care
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Spiritual care or psychotherapy/ meditation 

Spiritual care sessions with a chaplain or psychotherapy/meditation sessions with psychotherapist/ meditation instructor (per patients' choice which intervention) will be provided once per week for 24 weeks. For the chaplain-provided spiritual care, ONC-5 and the Chaplaincy Taxonomy will be utilized for intervention and assessment. Each session will be one hour. Sessions will be in-person with virtual modifications as needed. All patients will also receive  SOC and palliative measures plus chemotherapy if recommended.
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	SOC and palliative measures plus chemotherapy if recommended.
					
Cycle 20	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 0 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.

All concomitant medications received within 28 days before the start of trial and 30 days after the last trial intervention should be recorded.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serious Adverse Events.

 All AEs from the time of trial treatment initiation through 30 days after the last trial intervention should be recorded and must be reported by the investigator. 
All SAEs from baseline through 30 days after the last trial intervention should be recorded and must be reported by the investigator. For the time period beginning when the consent form is signed until trial treatment initiation, any SAE or follow-up to a SAE including death due to any cause that occurs to any patient must be reported within 24 hours to the Sponsor ( CTOMgmt@houstonmethodist.org  and/or ORS@houstonmethodist.org) if it causes the patient to be excluded from the trial or is the result of a protocol-specified intervention.
			Supportive Care
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Spiritual care or psychotherapy/ meditation 

Spiritual care sessions with a chaplain or psychotherapy/meditation sessions with psychotherapist/ meditation instructor (per patients' choice which intervention) will be provided once per week for 24 weeks. For the chaplain-provided spiritual care, ONC-5 and the Chaplaincy Taxonomy will be utilized for intervention and assessment. Each session will be one hour. Sessions will be in-person with virtual modifications as needed. All patients will also receive  SOC and palliative measures plus chemotherapy if recommended.
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	SOC and palliative measures plus chemotherapy if recommended.
			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Correlative blood collection will be performed at baseline and every 4 weeks for 24 weeks (6 blood draws). Blood will be collected into standard vacutainer tubes (3 green top tubes).
					
Cycles 21 to 23	Repeat 3 times	Cycle length: 7 days	Day 1	Perform every 0 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.

All concomitant medications received within 28 days before the start of trial and 30 days after the last trial intervention should be recorded.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serious Adverse Events.

 All AEs from the time of trial treatment initiation through 30 days after the last trial intervention should be recorded and must be reported by the investigator. 
All SAEs from baseline through 30 days after the last trial intervention should be recorded and must be reported by the investigator. For the time period beginning when the consent form is signed until trial treatment initiation, any SAE or follow-up to a SAE including death due to any cause that occurs to any patient must be reported within 24 hours to the Sponsor ( CTOMgmt@houstonmethodist.org  and/or ORS@houstonmethodist.org) if it causes the patient to be excluded from the trial or is the result of a protocol-specified intervention.
			Supportive Care
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Spiritual care or psychotherapy/ meditation 

Spiritual care sessions with a chaplain or psychotherapy/meditation sessions with psychotherapist/ meditation instructor (per patients' choice which intervention) will be provided once per week for 24 weeks. For the chaplain-provided spiritual care, ONC-5 and the Chaplaincy Taxonomy will be utilized for intervention and assessment. Each session will be one hour. Sessions will be in-person with virtual modifications as needed. All patients will also receive  SOC and palliative measures plus chemotherapy if recommended.
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	SOC and palliative measures plus chemotherapy if recommended.
					
Cycle 24	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 0 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.

All concomitant medications received within 28 days before the start of trial and 30 days after the last trial intervention should be recorded.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serious Adverse Events.

 All AEs from the time of trial treatment initiation through 30 days after the last trial intervention should be recorded and must be reported by the investigator. 
All SAEs from baseline through 30 days after the last trial intervention should be recorded and must be reported by the investigator. For the time period beginning when the consent form is signed until trial treatment initiation, any SAE or follow-up to a SAE including death due to any cause that occurs to any patient must be reported within 24 hours to the Sponsor ( CTOMgmt@houstonmethodist.org  and/or ORS@houstonmethodist.org) if it causes the patient to be excluded from the trial or is the result of a protocol-specified intervention.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Psychological Questionnaires 

Standardized psychological questionnaires (FACT-G, DASS-42, AAQ, ACE, ECRR, FACIT-Sp-Ex and Benefit Finding) will be completed by patients upon recruitment and after the last session (for questionnaires, see Appendix 1).
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Burnout Questionnaires 

Physician and caretaker burnout questionnaires (MBI, PROMIS and PFI) will be administered at baseline and every 6 months (for questionnaires, see Appendix 2).
			Supportive Care
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Spiritual care or psychotherapy/ meditation 

Spiritual care sessions with a chaplain or psychotherapy/meditation sessions with psychotherapist/ meditation instructor (per patients' choice which intervention) will be provided once per week for 24 weeks. For the chaplain-provided spiritual care, ONC-5 and the Chaplaincy Taxonomy will be utilized for intervention and assessment. Each session will be one hour. Sessions will be in-person with virtual modifications as needed. All patients will also receive  SOC and palliative measures plus chemotherapy if recommended.
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	SOC and palliative measures plus chemotherapy if recommended.
			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Correlative blood collection will be performed at baseline and every 4 weeks for 24 weeks (6 blood draws). Blood will be collected into standard vacutainer tubes (3 green top tubes).
					
EOS	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 0 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.

All concomitant medications received within 28 days before the start of trial and 30 days after the last trial intervention should be recorded.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serious Adverse Events.

 All AEs from the time of trial treatment initiation through 30 days after the last trial intervention should be recorded and must be reported by the investigator. 
All SAEs from baseline through 30 days after the last trial intervention should be recorded and must be reported by the investigator. For the time period beginning when the consent form is signed until trial treatment initiation, any SAE or follow-up to a SAE including death due to any cause that occurs to any patient must be reported within 24 hours to the Sponsor ( CTOMgmt@houstonmethodist.org  and/or ORS@houstonmethodist.org) if it causes the patient to be excluded from the trial or is the result of a protocol-specified intervention.