Telephone Support for Advanced Gastrointestinal Cancer

Recruiting at 3 trial locations

Overseen By Hannah Mullin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Psychiatric impairment, Cognitive impairment, Hospice care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 6 weeks

488 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new telephone counseling program, the Telephone Support Program, can help patients with advanced gastrointestinal cancer and their family caregivers manage stress and improve quality of life. It compares two approaches: one focuses on strategies like mindfulness and goal-setting, while the other provides education and support resources. The study aims to determine if the counseling program can reduce the impact of patients' fatigue and ease caregivers' feelings of burden. This trial may suit patients experiencing moderate to severe fatigue since their cancer diagnosis and their caregivers who provide frequent support. Participants will engage in weekly phone sessions over several months. As an unphased trial, this study offers a unique opportunity to contribute to innovative support strategies that could enhance quality of life for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on telephone support rather than medication changes.

What prior data suggests that this telephone support program is safe for patients and caregivers?

Research has shown that telephone support programs, such as the Acceptance and Commitment Therapy (ACT) used in this trial, are generally well-received by patients. In past studies, participants found these programs acceptable and feasible. No major reports have linked negative effects directly to the therapy itself.

ACT includes mindfulness exercises and personal goal-setting, which many patients find helpful for managing stress and symptoms. The comfort and safety of participating in a phone-based program make it an attractive option for people with advanced gastrointestinal cancer. Overall, evidence suggests that this type of support is safe and can effectively manage emotional and mental well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two innovative support methods for advanced gastrointestinal cancer patients and their caregivers. Unlike traditional treatments that primarily focus on direct medical intervention, this trial examines the benefits of psychological and educational support. The Acceptance and Commitment Therapy arm introduces mindfulness exercises and value-based goal setting, offering patients new ways to manage internal experiences like fatigue and distress. Meanwhile, the Education/Support arm provides comprehensive resources and guidance on navigating healthcare systems and addressing quality-of-life concerns. This trial aims to determine how these supportive interventions can enhance overall well-being alongside standard cancer treatments.

What evidence suggests that this trial's telephone support programs could be effective for advanced gastrointestinal cancer?

This trial will compare Acceptance and Commitment Therapy (ACT) with an Education/Support program for people with advanced gastrointestinal cancer and their caregivers. Research has shown that ACT might reduce tiredness and stress by teaching new ways to handle stress and discomfort. Participants practice mindfulness exercises and set goals based on personal values, which helps them manage tiredness more effectively. This approach has shown promise compared to providing only education and support. Overall, early findings suggest that ACT could significantly improve coping with cancer-related challenges. ^{1 4 6 7 8}

Who Is on the Research Team?

Catherine E Mosher, Ph.D.

Principal Investigator

Indiana University Indianapolis

Are You a Good Fit for This Trial?

This trial is for patients with advanced gastrointestinal cancer and their family caregivers. Participants must be willing to engage in weekly telephone sessions and interviews over approximately 5 months. Specific eligibility criteria are not provided, but typically include factors like age, health status, and the stage of cancer.

Inclusion Criteria

Patient can speak and read English

Family caregiver identified by a gastrointestinal cancer patient who meets the eligibility criteria

Caregiver has significant caregiving burden

Exclusion Criteria

My caregiver cannot participate due to hearing impairment.

I can do only a little activity daily.

I am currently receiving hospice care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants complete a 35-minute individual phone assessment at baseline

1 week

1 phone assessment

Treatment

Participants receive six weekly 50-minute telephone sessions of either ACT or education/support

6 weeks

6 phone sessions

Booster Session

Participants complete a 30-minute booster phone session one month after the 2-week follow-up

1 session

1 phone session

Follow-up

Participants are monitored for outcomes at 2 weeks and 3 months post-intervention

3 months

3 phone interviews

What Are the Treatments Tested in This Trial?

Interventions

• Telephone Support Program

Trial Overview The study compares two types of telephone support: one offers counseling with stress management strategies (Acceptance and Commitment Therapy), while the other provides education on quality-of-life issues. The aim is to see which program better reduces patient fatigue impact and caregiver burden.

How Is the Trial Designed?

Group I: Acceptance and Commitment Therapy Experimental Treatment 1 Intervention

Across six weekly 50-minute sessions and a booster session, advanced gastrointestinal cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a compact disc (CD) that the team developed to guide mindfulness practices.

Group II: Education/Support Active Control 1 Intervention

Across six weekly 50-minute sessions and a booster session, advanced gastrointestinal cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

Eskenazi Health

Collaborator

Trials

14

Recruited

3,700+

Published Research Related to This Trial

The study evaluated 54 recorded sessions of a telephone-based Acceptance & Commitment Therapy (ACT) intervention for smoking cessation, finding high adherence (average score of 4.61) and competence (average score of 4.81) among therapists.

The results indicate that ACT can be effectively delivered via telephone, suggesting it could be a valuable method for future research and interventions targeting smoking cessation and other behavioral changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Acceptance & Commitment Therapy be delivered with fidelity as a brief telephone-intervention? Schimmel-Bristow, A., Bricker, JB., Comstock, B.[2021]

Acceptance and Commitment Therapy (ACT) has been shown to significantly reduce anxiety, depression, and fear of cancer recurrence in a systematic review of 13 studies involving 537 cancer survivors.

The review suggests that ACT can improve psychological flexibility and quality of life for cancer survivors, but highlights the need for more rigorous studies to explore its effects on other symptoms like pain and insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy in adult cancer survivors: a systematic review and conceptual model. Mathew, A., Doorenbos, AZ., Jang, MK., et al.[2023]

In a pilot study involving 40 patient-caregiver dyads with advanced gastrointestinal cancer, telephone-based acceptance and commitment therapy (ACT) showed feasibility and led to moderate reductions in pain severity and depressive symptoms for patients at 2 weeks and 3 months post-intervention.

Caregivers also benefited from ACT, experiencing moderate reductions in sleep disturbances and cognitive concerns, suggesting that this intervention may effectively address the symptom burden for both patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of acceptance and commitment therapy on physical and psychological symptoms in advanced gastrointestinal cancer patients and caregivers: Secondary results of a pilot randomized trial. Burns, MF., Secinti, E., Johns, SA., et al.[2023]

A pilot study involving 25 cancer patients tested an Acceptance and Commitment Therapy (ACT) group intervention, showing promising results in reducing fear of progression, depression, and psychological inflexibility, while improving psychological health-related quality of life and well-being.

The high adherence rate among participants suggests that the ACT-based intervention is feasible for use in outpatient settings, although further research with randomized controlled trials is needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development and Evaluation of an Acceptance and Commitment Therapy (ACT)-Based Group Intervention for Cancer Patients with Psychological Burden]. Sauer, C., Maatouk, I.[2022]

This pilot trial will evaluate a novel acceptance and commitment therapy (ACT) intervention for advanced gastrointestinal cancer patients experiencing moderate-to-severe fatigue and their family caregivers, aiming to improve both patient fatigue interference and caregiver burden.

The study will involve at least 40 patient-caregiver dyads participating in six weekly telephone sessions, assessing outcomes such as fatigue interference, caregiver burden, and quality of life at multiple time points, which will help inform future larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy for fatigue interference in advanced gastrointestinal cancer and caregiver burden: protocol of a pilot randomized controlled trial. Mosher, CE., Secinti, E., Kroenke, K., et al.[2021]

Acceptance and Commitment Therapy (ACT) is a promising psychological intervention that helps terminally ill cancer patients manage physical, psychological, and social challenges, ultimately enhancing their quality of life.

There is strong evidence from international studies supporting the effectiveness of ACT in improving health-related outcomes for patients, caregivers, and healthcare professionals, highlighting the need for further research in South Korea's hospice and palliative care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Acceptance and Commitment Therapy (ACT) in Hospice and Palliative Care Settings. Park, SY.[2023]

A study involving 203 post-treatment cancer survivors identified three symptom severity classes, revealing that those with higher symptom burdens (like fatigue and anxiety) showed lower levels of mindfulness and acceptance.

The results support the Acceptance and Commitment Therapy (ACT) model, suggesting that survivors with greater symptom distress are less engaged in meaningful activities and less accepting of their experiences, highlighting the need for further research on ACT's effectiveness in alleviating suffering in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom experiences in post-treatment cancer survivors: associations with acceptance and commitment therapy constructs. Lewson, AB., Johns, SA., Krueger, E., et al.[2022]

Acceptance and Commitment Therapy (ACT) delivered via telephone was found to be more satisfying and engaging for participants compared to standard quitline (QL) coaching, with 92% of ACT participants finding it useful for quitting smoking.

Both ACT and QL coaching had similar effectiveness in achieving smoking cessation at the 12-month follow-up, with 24.6% of ACT participants and 28.8% of QL participants reporting abstinence, suggesting that ACT could be a beneficial alternative for those struggling to quit with traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Full-scale Randomized Trial Comparing Acceptance and Commitment Therapy Telephone-Delivered Coaching With Standard Telephone-Delivered Coaching Among Medicare/Uninsured Quitline Callers. Bricker, JB., Sullivan, BM., Mull, KE., et al.[2023]

A randomized controlled trial involving 156 colorectal cancer patients showed that a self-management program based on acceptance and commitment therapy significantly improved anxiety, depression, fatigue, and quality of life over six months.

The intervention, which included personal skills training and follow-up support, helped patients manage symptoms and adjust psychologically, although it did not significantly change physical activity or fruit and vegetable intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a self-management program on quality of life in colorectal cancer patients: A randomized controlled trial. Wang, TJ., Chang, SC., Hsu, HH., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04010227

Telephone Support for Advanced Gastrointestinal Cancer ... This trial evaluates the feasibility, acceptability, and preliminary efficacy of telephone-based Acceptance and Commitment Therapy (ACT) on fatigue interference ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10100868/

Impact of acceptance and commitment therapy on physical ... Findings suggest that ACT may improve certain symptoms in dyads coping with advanced gastrointestinal cancer and warrant replication in a larger trial.

3. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct04010227

Telephone Support for Advanced Gastrointestinal Cancer ... The investigators hypothesize that ACT will lead to improved primary and secondary outcomes as compared to education/support. Study findings will inform a large ...

4. withpower.com withpower.com/trial/phase-gastrointestinal-neoplasms-7-2024-2a59f

Telephone Support for Advanced Gastrointestinal Cancer The goal of this clinical trial is to see if telephone support programs help patients and their family caregivers adjust to advanced gastrointestinal cancer ...

5. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-021-00837-9

Acceptance and commitment therapy for fatigue interference ... This pilot RCT examines the feasibility and acceptability of delivering telephone-based ACT to advanced GI cancer patient-caregiver dyads.

6. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct06532877

Telephone Support in Advanced Gastrointestinal Cancer The goal of this clinical trial is to see if telephone support programs help patients and their family caregivers adjust to advanced gastrointestinal cancer ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37064761/

Secondary results of a pilot randomized trial - PubMed Findings suggest that ACT may improve certain symptoms in dyads coping with advanced gastrointestinal cancer and warrant replication in a larger trial.

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06532877/telephone-support-in-advanced-gastrointestinal-cancer

Telephone Support in Advanced Gastrointestinal Cancer The goal of this clinical trial is to see if telephone support programs help patients and their family caregivers adjust to advanced ...