Efficacy of a Couple-Focused mHealth Symptom Self-management Program

Testing the Efficacy of a Couple-Focused, Tailored mHealth Intervention for Symptom Self-Management Among Men With Prostate Cancer and Their Partners

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03489057

Enrollment

560

Registered

2018-04-05

Start date

2018-05-30

Completion date

2022-07-31

Last updated

2024-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

symptom, family research, self-management, caregiving, social support, mHealth, healthy behavior, self-efficacy, quality of life, care transition

Brief summary

In this study, the investigators propose to test the efficacy of a couple-focused, web-based tailored prostate cancer symptom management program, Prostate Cancer Education and Resources for Couples (PERC) in a randomized clinical trial. A two-group (PERC versus National Cancer Institute (NCI) website plus treatment as usual) randomized controlled design will be used, and data will be collected at baseline (T1), 4 (T2), 8 (T3), and 12 months (T4) among 300 patients completing initial treatment for localized prostate cancer and their intimate partners (i.e., 600 participants in total).

Detailed description

This randomized clinical trial aims to test the efficacy of a couple-focused, web-based tailored prostate cancer symptom management program, Prostate Cancer Education and Resources for Couples (PERC). The study participants will include 300 patients completing initial treatment for localized prostate cancer and their intimate partners (i.e., 300 dyads and 600 individuals). After informed consent, we will conduct baseline assessment (T1), randomly assign eligible participants to either PERC or the National Cancer Institute (NCI) website, and then collect data at 4 (T2), 8 (T3), and 12 months (T4) post-T1.

Interventions

BEHAVIORALProstate Cancer Education and Resources for Couples (PERC)

PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.

BEHAVIORALusual care plus NCI website

The usual care plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

The investigator and data collectors will be masked to intervention.

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

The eligible patients must 1. be 40 to 75 years of age 2. be within 16 weeks (4 months) after completing initial treatment for localized prostate cancer as confirmed by patient and biopsy pathology report) with curative intent, i.e., surgery or radiotherapy +/- hormonal treatment; 3. have no previous cancer history within the past 2 years and not currently in treatment for cancer, or have a concurrent cancer (excluding non-melanomatous skin cancer); 4. experience prostate cancer-specific and/or general symptoms; 5. have a partner who is willing to participate. The eligible partners must 1. be 18 years or older 2. be identified as the partner by the patient 3. not have been diagnosed with cancer or receiving treatment for cancer within the past 12 months (non-melanomatous skin cancer diagnosis/treatment is acceptable) so that couples can focus their efforts on managing prostate cancer.

Exclusion criteria

Patients and their partners will be excluded from the study if they: * Do not read and speak English (evidenced by their understanding and responses to screening questions and self-reported ability to read English); * Have cognitive impairment (assessed by the Short Portable Mental Status Questionnaire).

Design outcomes

Primary

Measure	Time frame	Description
Change in Quality of Life Over Time as Assessed by Functional Assessment of Cancer Treatment (FACT-G) Scores	Baseline, month 4, 8 and 12	The Functional Assessment of Cancer Therapy - General (FACT-G) is used to measure change in quality of life of patient and partner from baseline (T1) to T2 (4 months post-T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Functional assessment of Cancer Therapy-General is a 27-item survey which assesses physical, social/family, emotional, and functional well-being on a 5-point Likert scale, with 0 indicating not at all and 4 indicating very much in response to item questions. The total FACT-G score is calculated as the sum of four sub scores including physical, social/family, emotional, and functional well-being. Total scores range between 0-108. Higher scores indicated better well-being. It has also demonstrated sensitivity to change over time.

Secondary

Measure	Time frame	Description
Change in Fatigue From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by The Functional Assessment of Cancer Therapy - General (FACT-G) Scores	Baseline, month 4, 8, and 12	FACT-G is used to measure the change in the quality of life of patients and partners from baseline (T1) to T2 (4 months post-T1), T3 (8 months post-T1), and T4 (12 months post-T1). Change from baseline is the post-baseline values minus the Baseline value. Functional Assessment of Cancer Therapy-General is a 27-item survey that assesses physical, social/family, emotional, and functional well-being on a 5-point Likert scale, with 0 indicating not at all and 4 indicating very much in response to item questions. The total FACT-G score is calculated as the sum of four sub-scores including physical, social/family, emotional, and functional well-being. Total scores range between 0-108. Higher scores indicated better well-being. It has also demonstrated sensitivity to change over time.
Change in Sleep Disturbance From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS Scores	Baseline, month 4, 8, and 12	PROMIS Sleep Disturbance Short Form 8b is used to examine change in sleep quality of patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Required by the PROMIS scoring instrument, for all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The sleep disturbance sub-scale measured the extent to which participants experienced sleep disturbance over the past 7 days using a 5-point Likert scale. Higher scores reflect greater sleep disturbance. Score value ranges between 28.9-76.5.
Change in Anxiety From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS-Emotional Distress-Anxiety Short Form	Baseline, month 4, 8, and 12	PROMIS-Emotional Distress-Anxiety Short Form 7a is used to examine change in anxiety among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). For all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The anxiety sub-scale of the PROMIS item bank measures the extent to which participants experience anxiety symptoms over the past 7 days using a 5-point Likert scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with the total scores range from 36.3 to 82.7 with higher scores reflect higher anxiety.
Change in Depression From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS-Emotional Distress-Depression	Baseline, month 4, 8, and 12	PROMIS-Emotional Distress-Depression Short From 8b is used to measure the change in depression scores among patients from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Required by the PROMIS scoring instrument, for all PROMIS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The depression sub-scale of the PROMIS item bank measures the extent to which participants experience depressive symptoms in the past 7 days using a 5-point Likert scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with the total scores range from 24.7 to 63.5 with higher scores indicate greater depressive symptoms.
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Urinary Symptom Score (Patient Only)	Baseline, month 4, 8, and 12	Urinary symptom scores change by time were measured using patients' self-assessed urinary symptoms subscale of the Expanded Prostate Cancer Index Composite Short Form (EPIC 26) which is designed to evaluate patient urinary function and bother after prostate cancer treatment. EPIC26 was used at Baseline (T1) to T2 (4 months post-T1), T3 (8 months post-T1), and T4 (12 months post-T1). EPIC26 evaluates patients' functional and symptom-specific issues, including urinary, bowel, sexual, and hormonal symptoms and bother. The patient self-report contains 26 items, and the score range is 0-100. Higher scores represent fewer prostate cancer symptoms and better prostate cancer-related quality of life.
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Bowel Symptom Score (Patient Only)	Baseline, month 4, 8, and 12	Bowel symptom scores change by time and were measured using patients' self-assessed bowel symptoms subscale of the Expanded Prostate Cancer Index Composite Short Form (EPIC 26) which is designed to evaluate patient function and bother after prostate cancer treatment. EPIC was used at Baseline (T1) to T2 (4 months post-T1), T3 (8 months post-T1), and T4 (12 months post-T1). EPIC26 evaluates patients' functional and symptom-specific issues, including urinary, bowel, sexual, and hormonal symptoms and bother. The patient self-report contains 26 items, and the score range is 0-100. Higher scores represent fewer prostate cancer symptoms and better prostate cancer-related quality of life.
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Sexual Symptom Score (Patients Only)	Baseline, month 4, 8, and 12	Sexual symptom scores change by time were measured using patients' self-assessed sexual symptoms subscale of the Expanded Prostate Cancer Index Composite Short Form (EPIC 26) which is designed to evaluate patient function and bother after prostate cancer treatment. EPIC was used at Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). EPIC26 evaluates patients' functional and symptom-specific issues, including urinary, bowel, sexual, and hormonal symptoms and bother. The patient self-report contains 26 items, and the score range is 0-100. Higher scores represent fewer prostate cancer symptoms and better prostate cancer-related quality of life.
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Hormonal Symptom Score (Patient Only)	Baseline, month 4, 8, and 12	Hormonal symptom scores change by time were measured using patients' self-assessed hormonal subscale of the Expanded Prostate Cancer Index Composite Short Form (EPIC 26) which is designed to evaluate patient function and bother after prostate cancer treatment. EPIC was used at Baseline (T1) to T2 (4 months post-T1), T3 (8 months post-T1), and T4 (12 months post-T1). EPIC26 evaluates patients' functional and symptom-specific issues, including urinary, bowel, sexual, and hormonal symptoms and bother. The patient self-report contains 26 items, and the score range is 0-100. Higher scores represent fewer prostate cancer symptoms and better prostate cancer-related quality of life.
Change in Pain From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by Patient-Reported Outcome Measurement Information System (PROMIS) Scores	Baseline, month 4, 8, and 12	PROMIS Pain Interference - Short Form 6b is used to measure change in Pain Interference among patients and their partners from Baseline (T1) to T2 (4 months post-T1), T3 (8-mon post-T1), and T4 (12-mon post-T1). Required by PROMIS scoring instrument, for all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The pain measures the extent to which patients experience problems with pain over the past 7 days using a 5-point Likert scale. Higher scores reflect greater Pain Interference. The score value ranges between 41-78.3.
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Bowel Symptom (Partners Only)	Baseline, month 4, 8, and 12	Bowel symptom scores change by time were measured using caregiver-assessed bowel symptoms subscale of the 4-item caregiver version of the Expanded Prostate Cancer Index Composite Short Form which is designed to assess how much of a bother/burden patients' prostate cancer symptoms were for the partners themselves. EPIC-caregiver was used Baseline (T1) to T2 (4 months post T1), T3 (8 months post-T1), and T4 (12 months post-T1). The partner reported how patients' urinary and bowel, sexual, and hormonal symptoms bothered the caregivers. The score range is 0-100. Higher scores represent fewer bother partners reported and better prostate cancer-related quality of life.
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Hormonal Symptom Score Partners Only)	Baseline, month 4, 8, and 12	Hormonal symptom scores change by time were measured using caregiver-assessed hormonal subscale of the 4-item caregiver version of the Expanded Prostate Cancer Index Composite Short Form which is designed to assess how much of a bother/burden patients' prostate cancer symptoms were for the partners themselves. EPIC-caregiver was used Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12 months post-T1). The partner reported how patients' urinary and bowel, sexual, and hormonal symptoms bothered the caregivers. The score range is 0-100. Higher scores represent fewer bother partners reported and better prostate cancer-related quality of life.
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Sexual Symptom Score Partners Only)	Baseline, month 4, 8, and 12	Sexual symptom scores change by time were measured using caregiver assessed sexual symptoms subscale of the 4-item caregiver version of the Expanded Prostate Cancer Index Composite Short Form which is designed to assess how much of a bother/burden patients' prostate cancer symptoms were for the partners themselves. EPIC-caregiver was used Baseline (T1) to T2 (4 months post T1), T3 (8 months post-T1), and T4 (12 months post-T1). The partner reported how patients' urinary and bowel, sexual, and hormonal symptoms bothered the caregivers. The score range is 0-100. Higher scores represent fewer bother partners reported and better prostate cancer-related quality of life.
Change in Self-efficacy Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by the Lewis Cancer Self-Efficacy Scale	Baseline, month 4, 8, and 12	The Lewis Cancer Self-Efficacy will be used to measure change in patient and partner feelings of self-efficacy in dealing with the patient's cancer diagnosis and treatment from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Patients will rate statements about how confident they feel on a scale from 1 to 10, where higher scores indicate higher self-efficacy.
Change in Informational Support Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS-Informational Support Short Form	Baseline, month 4, 8, and 12	The Patient-Reported Outcomes Measurement Information System (PROMIS) 8a is a National Institute of Health-funded initiative to develop and validate patient-reported outcomes (PROs) for clinical research and practice. PROMISE is a set of measures that evaluates and monitors physical, mental, and social health. It uses a 5-point Likert scale. The scoring process involved collecting PROMIS data from participants and calculating the PROMIS score as the sum of responses to each question. Then Health Measures Scoring Service was used to calculate the PROMIS T-score - the standardized score. Specifically, PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population (T-scores have a mean of 50 and a standard deviation (SD) of 10). On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.
Change in Instrumental Support Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Measured by PROMIS Instrumental Support-Short Form 8a	Baseline, month 4, 8, and 12	The Patient-Reported Outcomes Measurement Information System (PROMIS) 8a is a National Institute of Health-funded initiative to develop and validate patient-reported outcomes (PROs) for clinical research and practice. PROMISE is a set of measures that evaluates and monitors physical, mental, and social health. It uses a 5-point Likert scale. The scoring process involved collecting PROMIS data from participants and calculating the PROMIS score as the sum of responses to each question. Then Health Measures Scoring Service was used to calculate the PROMIS T-score - the standardized score. Specifically, PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population (T-scores have a mean of 50 and a standard deviation (SD) of 10). On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.
Change in Appraisal of Illness Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Measured by Appraisal of Illness Scale	Baseline, month 4, 8, and 12	The appraisal of Illness scale is used to measure changes in perception of prostate cancer and related issues among patients and their partners. The Appraisal of Illness scale is a 20-item measure that uses Likert Scales ranging from 1 to 5 (very false to very true). The score range is 1-5. The higher score indicated a better cognitive appraisal of the illness the patient or partner had. The score is calculated by the Prorated mean scale scores. The formula is prorated scale score =\[SUM OF ITEM SCORES\]x\[N OF ITEMS IN SCALE\]/\[N OF ITEMS ANSWERED\]. Measurements were performed at baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-baseline values minus the baseline value. Higher scores indicate better support.
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Urine Symptom Score (Partners Only)	Baseline, month 4, 8, and 12	Urinary symptom scores change by time were measured using caregiver assessed urinary symptoms subscale of the 4-item caregiver version of the Expanded Prostate Cancer Index Composite Short Form which is designed to assess how much of a bother/burden patients' prostate cancer symptoms were for the partners themselves. EPIC-caregiver was used Baseline (T1) to T2 (4 months post-T1), T3 (8 months post-T1), and T4 (12 months post-T1). The partner reported how patients' urinary and bowel, sexual, and hormonal symptoms bothered the caregivers. The score range is 0-100. Higher scores represent fewer bother partners reported and better prostate cancer-related quality of life.

Countries

United States

Participant flow

Recruitment details

We recruited 280 patients with newly treated localized prostate cancer and their partner caregivers, with a total of 560 individuals into the study

Pre-assignment details

All participants completed informed consent and the baseline assessment of quality of life, symptoms, and their stress-coping processes.

Participants by arm

Arm	Count
PERC Program Prostate Cancer Education and Resources for Couples (PERC) program. Participants assigned to experimental condition will receive access to the PERC website. Prostate Cancer Education and Resources for Couples (PERC): PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.	141
Caregivers of Participants Receive PERC Prostate Cancer Education and Resources for Couples (PERC) program. Participants assigned to the experimental condition will receive access to the PERC website. Caregivers of participants receive PERC. Prostate Cancer Education and Resources for Couples (PERC): PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.	141
Participants Receive Usual Care Participants in this usual care plus NCI website group will be automatically directed to the NCI prostate cancer website after logging in to the study website homepage. Usual Care Plus NCI website: The usual Care Plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll-free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.	139
Caregivers of Participants Receive Usual Care Caregivers of participants receive usual care. Participants in this usual care plus NCI website group will be automatically directed to the NCI prostate cancer website after logging in to the study website homepage. Usual Care Plus NCI website: The usual Care Plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll-free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.	139
Total	560

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Lost to Follow-up	16	16	14	14
Overall Study	Protocol Violation	7	7	2	2
Overall Study	Withdrawal by Subject	12	12	8	8

Baseline characteristics

Characteristic	PERC Program	Total	Caregivers of Participants Receive Usual Care	Participants Receive Usual Care	Caregivers of Participants Receive PERC
Age, Continuous	64.33 years STANDARD_DEVIATION 6.87	62.41 years STANDARD_DEVIATION 7.17	60.83 years STANDARD_DEVIATION 7.5	63.10 years STANDARD_DEVIATION 6.55	61.38 years STANDARD_DEVIATION 7.23
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants	14 Participants	2 Participants	2 Participants	6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	135 Participants	539 Participants	134 Participants	135 Participants	135 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants	7 Participants	3 Participants	2 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants	4 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	1 Participants	8 Participants	3 Participants	1 Participants	3 Participants
Race (NIH/OMB) Black or African American	28 Participants	111 Participants	28 Participants	30 Participants	25 Participants
Race (NIH/OMB) More than one race	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	8 Participants	2 Participants	0 Participants	4 Participants
Race (NIH/OMB) White	107 Participants	427 Participants	104 Participants	108 Participants	108 Participants
Region of Enrollment United States	141 participants	560 participants	139 participants	139 participants	141 participants
Sex: Female, Male Female	0 Participants	279 Participants	138 Participants	0 Participants	141 Participants
Sex: Female, Male Male	141 Participants	281 Participants	1 Participants	139 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 141	0 / 139
other Total, other adverse events	0 / 141	0 / 139
serious Total, serious adverse events	3 / 141	1 / 139

Outcome results

Primary

Change in Quality of Life Over Time as Assessed by Functional Assessment of Cancer Treatment (FACT-G) Scores

The Functional Assessment of Cancer Therapy - General (FACT-G) is used to measure change in quality of life of patient and partner from baseline (T1) to T2 (4 months post-T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Functional assessment of Cancer Therapy-General is a 27-item survey which assesses physical, social/family, emotional, and functional well-being on a 5-point Likert scale, with 0 indicating not at all and 4 indicating very much in response to item questions. The total FACT-G score is calculated as the sum of four sub scores including physical, social/family, emotional, and functional well-being. Total scores range between 0-108. Higher scores indicated better well-being. It has also demonstrated sensitivity to change over time.

Time frame: Baseline, month 4, 8 and 12

Population: The number reported in the results is based on participants.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Baseline -PERC	Change in Quality of Life Over Time as Assessed by Functional Assessment of Cancer Treatment (FACT-G) Scores	89.48 score on a scale	Standard Deviation 12.92
PERC 4-months	Change in Quality of Life Over Time as Assessed by Functional Assessment of Cancer Treatment (FACT-G) Scores	90.54 score on a scale	Standard Deviation 12.98
PERC 8-months	Change in Quality of Life Over Time as Assessed by Functional Assessment of Cancer Treatment (FACT-G) Scores	90.29 score on a scale	Standard Deviation 14.49
PERC 12-months	Change in Quality of Life Over Time as Assessed by Functional Assessment of Cancer Treatment (FACT-G) Scores	90.42 score on a scale	Standard Deviation 12.58
Baseline Usual Care	Change in Quality of Life Over Time as Assessed by Functional Assessment of Cancer Treatment (FACT-G) Scores	88.38 score on a scale	Standard Deviation 14.82
Usual Care 4 Months	Change in Quality of Life Over Time as Assessed by Functional Assessment of Cancer Treatment (FACT-G) Scores	90.18 score on a scale	Standard Deviation 15.4
Usual Care 8 Months	Change in Quality of Life Over Time as Assessed by Functional Assessment of Cancer Treatment (FACT-G) Scores	89.07 score on a scale	Standard Deviation 15.39
Usual Care 12 Months.	Change in Quality of Life Over Time as Assessed by Functional Assessment of Cancer Treatment (FACT-G) Scores	88.07 score on a scale	Standard Deviation 16.87

p-value: 0.19Mixed Models Analysis

Secondary

Change in Anxiety From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS-Emotional Distress-Anxiety Short Form

PROMIS-Emotional Distress-Anxiety Short Form 7a is used to examine change in anxiety among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). For all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The anxiety sub-scale of the PROMIS item bank measures the extent to which participants experience anxiety symptoms over the past 7 days using a 5-point Likert scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with the total scores range from 36.3 to 82.7 with higher scores reflect higher anxiety.