Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532877
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Telephone Support in Advanced Gastrointestinal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Telephone Support Program for Patients With Advanced Gastrointestinal Cancer and Their Family Caregivers
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to see if telephone support programs help patients and their family caregivers adjust to advanced gastrointestinal cancer A new telephone counseling program that involves practicing strategies for managing stress and symptoms will be compared to a telephone program involving education on quality-of-life issues and psychosocial support The main questions it aims to answer are
Does our telephone counseling program lower the negative impact of patients fatigue on their activities emotions and thinking abilities compared to a telephone program involving education and support Does our telephone counseling program lower family caregivers feelings of burden compared to a telephone program involving education and support
Participants in both study conditions will
Complete 6 weekly telephone sessions of counseling or educationsupport Complete a telephone booster session Complete 3 telephone interviews over about 5 months
Does our telephone counseling program lower the negative impact of patients fatigue on their activities emotions and thinking abilities compared to a telephone program involving education and support Does our telephone counseling program lower family caregivers feelings of burden compared to a telephone program involving education and support
Participants in both study conditions will
Complete 6 weekly telephone sessions of counseling or educationsupport Complete a telephone booster session Complete 3 telephone interviews over about 5 months
Detailed Description:
This trial tests the effects of telephone-delivered acceptance and commitment therapy ACT on patient fatigue interference with functioning and family caregiver burden in advanced gastrointestinal GI cancer Aim 1 as well as secondary outcomes Aim 2 This trial also examines increases in psychological flexibility as a hypothesized mediator of ACTs effects on patient fatigue interference and caregiver burden Aim 3 Finally two core aspects of psychological flexibility ie mindfulnessacceptance and commitmentbehavior change processes are examined as exploratory mediators of ACTs effects on patient fatigue interference and caregiver burden Aim 4 The investigators will recruit advanced GI cancer patients and caregivers from Indiana University Health Eskenazi Health MD Anderson Cancer Center and Northwestern University hospitals Potentially eligible patients will be mailed a study introductory letter along with a consent form The letter will have a number to call if they do not wish to be contacted further A research assistant will call all prospective participants who do not opt out approximately 1 to 2 weeks after the letter is mailed The research assistant will describe the study as outlined in the consent form and answer any questions Then the research assistant will administer an eligibility screening to those who consent to participate With the patients permission the primary family caregiver will also be mailed a consent form and contacted via phone to screen for eligibility and obtain consent Consenting patients and caregivers will complete a 35-minute individual phone assessment at baseline
Following baseline assessments patient-caregiver dyads N 244 will be randomly assigned in equal numbers to ACT or educationsupport using a stratified block randomization scheme to balance the groups by patient age 65 vs 65 years and performance status patient-reported Eastern Cooperative Oncology Group ECOG scores 0 or 1 vs 2 Dyads in both groups will complete six weekly 50-minute telephone sessions with the first session occurring one week after baseline Blind interviewers will assess outcomes during 30-minute individual phone assessments at 2 weeks and 3 months post-intervention Dyads in both conditions will also complete a 30-minute booster phone session one month after the 2-week follow-up During the booster session ACT therapists will reinforce and address any barriers to skill practice and educationsupport therapists will review key medical center and community resources
Following baseline assessments patient-caregiver dyads N 244 will be randomly assigned in equal numbers to ACT or educationsupport using a stratified block randomization scheme to balance the groups by patient age 65 vs 65 years and performance status patient-reported Eastern Cooperative Oncology Group ECOG scores 0 or 1 vs 2 Dyads in both groups will complete six weekly 50-minute telephone sessions with the first session occurring one week after baseline Blind interviewers will assess outcomes during 30-minute individual phone assessments at 2 weeks and 3 months post-intervention Dyads in both conditions will also complete a 30-minute booster phone session one month after the 2-week follow-up During the booster session ACT therapists will reinforce and address any barriers to skill practice and educationsupport therapists will review key medical center and community resources
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None