CompletedNot Applicable

Comparison of ACT and CBSM for Caregivers in Cancer

Iran66 participantsStarted 2024-06-24

Plain-language summary

The goal of this clinical trial is to compare the effectiveness of cognitive-behavioral stress management (CBSM) and acceptance and commitment therapy (ACT) on the fear of recurrence, quality of life, psychological distress, and fatigue of caregivers of cancer patients. Researchers compare the effectiveness of CBSM and ACT to a Control(without receiving intervention) to see if treatment works to improve the health of caregivers of cancer patients. A comparison between the two treatments was also conducted to determine if there was a difference in their effectiveness. Participants: In this study, 66 participants were randomly assigned to one of three groups: the CBSM group, the ACT group, or the control group. The CBSM and ACT groups each attended eight 90-minute, in-person sessions twice a week.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: To be included in the study, caregivers had to be 18 years or older, literate, and provide informed consent. A key requirement was that participants either lived with the patient or visited them at least twice a week. Exclusion Criteria: Exclusion criteria were applied to ensure the integrity of the study. Participants were excluded if they missed more than two sessions, were currently receiving other psychological interventions, had a major psychiatric or cognitive disorder that would prevent them from providing informed consent, or if the patient passed away.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fear of Cancer Recurrence Inventory-caregiver (FCRI-c)

Timeframe: assessments at three distinct time points: at baseline (pre-intervention), immediately following the four-week intervention period (post-test), and at a two-month follow-up.

Depression Anxiety and Stress (DASS)

Timeframe: assessments at three distinct time points: at baseline (pre-intervention), immediately following the four-week intervention period (post-test), and at a two-month follow-up.

Caregiver Quality of Life-Cancer (CQOLC)

Timeframe: assessments at three distinct time points: at baseline (pre-intervention), immediately following the four-week intervention period (post-test), and at a two-month follow-up.

Multidimensional Fatigue Inventory (MFI)

Timeframe: assessments at three distinct time points: at baseline (pre-intervention), immediately following the four-week intervention period (post-test), and at a two-month follow-up.

Trial details

NCT IDNCT07329868

SponsorArdakan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-22

View on ClinicalTrials.gov More Caregiver Burden trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Fear of Cancer Recurrence Inventory-caregiver (FCRI-c)

Timeframe: assessments at three distinct time points: at baseline (pre-intervention), immediately following the four-week intervention period (post-test), and at a two-month follow-up.

Depression Anxiety and Stress (DASS)

Timeframe: assessments at three distinct time points: at baseline (pre-intervention), immediately following the four-week intervention period (post-test), and at a two-month follow-up.

Caregiver Quality of Life-Cancer (CQOLC)

Timeframe: assessments at three distinct time points: at baseline (pre-intervention), immediately following the four-week intervention period (post-test), and at a two-month follow-up.

Multidimensional Fatigue Inventory (MFI)

Timeframe: assessments at three distinct time points: at baseline (pre-intervention), immediately following the four-week intervention period (post-test), and at a two-month follow-up.