A Multicomponent Support Program to Enhance Quality of Life in Chinese Cancer Patients and Survivors (MSP-CCS): Pilot Optimization Trial and Implementation Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 64
- Locations
- 7
- Primary Endpoint
- Proportion of eligible participants who enroll in the trial.
Study Overview
Brief Summary
The purpose of this study is to evaluate different combinations of cancer education sessions, counseling sessions, and peer support meetings developed for Chinese cancer patients and survivors. The researchers will look at whether the combinations are practical and effective, and how they impact participants' quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with cancer (any type/stage) (per EMR for MSK patients or self-report for external participants) within the last 5 years
- •Age ≥ 18 years (per EMR for MSK patients or self-report for external participants)
- •Self-Report Criteria:
- •Of Chinese descent
- •Speaks Mandarin "well" or "very well"
- •Moderately low HRQOL (<70 FACT-G score)4, 48
- •Resides in New York or New Jersey
- •Agrees to participate via telehealth (video or phone)
- •Agrees to be audio-recorded
Exclusion Criteria
- •Self-Report Criteria:
- •Per PI determination, requires a higher level of care for current passive or active suicidal ideation than current protocol is able to provide. If a participant receives a score of > 0 on item 9 of the PHQ-9,5 they will be referred to study PI for further evaluation using the Columbia-Suicide Severity Rating Scale. They will be excluded from participation in this study if there is presence of suicidal risk, determined by affirmative response(s) on the Columbia-Suicide Severity Rating Scale (C-SSRS)
- •Too ill to participate determined by the question: "Do you feel too ill to participate because of communication problems, uncontrollable pain, or other symptoms that prevent you from participating?"
- •Cognitive impairment (Montreal Cognitive Assessment 5 Minute - telephone version with a score < 12)
- •Per consenting professional determination, unable to understand the informed consent procedure
- •Participation in study #14-076: Adaptation of Individual Meaning-Centered Psychotherapy for Chinese immigrant cancer patients)
- •Currently receiving/have received psychotherapy/counseling/peer support within the last 6 months (patients being treated solely with psychotropic medications will not be excluded if they are not receiving psychotherapy/counseling/peer support)
Arms & Interventions
4 - Cancer Education + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions.
Intervention: Enhanced Standard Care (Other)
1 - Cancer Education + Meaning-Centered Counseling + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions.Counseling sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings.
Intervention: Cancer Education (Other)
1 - Cancer Education + Meaning-Centered Counseling + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions.Counseling sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings.
Intervention: Meaning-Centered Counseling (Other)
1 - Cancer Education + Meaning-Centered Counseling + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions.Counseling sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings.
Intervention: Peer Support (Other)
2 - Cancer Education + Meaning-Centered Counseling + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions.Counseling sessions, will have 3 weekly sessions.
Intervention: Enhanced Standard Care (Other)
5 - Meaning-Centered Counseling + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources.Counseling sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings
Intervention: Meaning-Centered Counseling (Other)
5 - Meaning-Centered Counseling + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources.Counseling sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings
Intervention: Enhanced Standard Care (Other)
5 - Meaning-Centered Counseling + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources.Counseling sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings
Intervention: Peer Support (Other)
1 - Cancer Education + Meaning-Centered Counseling + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions.Counseling sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings.
Intervention: Enhanced Standard Care (Other)
2 - Cancer Education + Meaning-Centered Counseling + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions.Counseling sessions, will have 3 weekly sessions.
Intervention: Cancer Education (Other)
2 - Cancer Education + Meaning-Centered Counseling + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions.Counseling sessions, will have 3 weekly sessions.
Intervention: Meaning-Centered Counseling (Other)
3 - Cancer Education + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings.
Intervention: Cancer Education (Other)
3 - Cancer Education + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings.
Intervention: Peer Support (Other)
3 - Cancer Education + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings.
Intervention: Enhanced Standard Care (Other)
4 - Cancer Education + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions.
Intervention: Cancer Education (Other)
6 - Meaning-Centered Counseling- + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Counseling sessions, will have 3 weekly sessions.
Intervention: Meaning-Centered Counseling (Other)
6 - Meaning-Centered Counseling- + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Counseling sessions, will have 3 weekly sessions.
Intervention: Enhanced Standard Care (Other)
7 - Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Peer support meetings, will have 3 monthly meetings
Intervention: Peer Support (Other)
7 - Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Peer support meetings, will have 3 monthly meetings
Intervention: Enhanced Standard Care (Other)
8 - Enhanced Standard Care
All participants will also receive cancer information materials and resources.
Intervention: Enhanced Standard Care (Other)
Outcomes
Primary Outcomes
Proportion of eligible participants who enroll in the trial.
Time Frame: 2 years
Proportion of participants who complete treatment
Time Frame: 24 weeks
Pproportion of assessments that are completed, with completion defined as submitting the 24-week assessment with a minimum of the FACT-G completed.
Secondary Outcomes
No secondary outcomes reported