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

Trial Summary

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 data supports the effectiveness of the treatment Telephone Support Program, Telephone Counseling Program, Telephone-Based Acceptance and Commitment Therapy (ACT), Education/Support Program for advanced gastrointestinal cancer?

Research shows that Acceptance and Commitment Therapy (ACT), which is part of the telephone support program, can help reduce pain, depressive symptoms, and sleep disturbances in patients and caregivers dealing with advanced gastrointestinal cancer. Although the study did not find significant differences between groups, patients and caregivers who received ACT experienced moderate improvements in these areas. ^{1 2 3 4 5}

Is telephone-based Acceptance and Commitment Therapy (ACT) safe for humans?

Research on telephone-based Acceptance and Commitment Therapy (ACT) for advanced gastrointestinal cancer patients and caregivers suggests it is safe, as no significant adverse effects were reported. It may even help reduce symptoms like pain, depression, sleep disturbances, and anxiety. ^{1 3 6 7 8}

How is the Telephone Support Program for advanced gastrointestinal cancer different from other treatments?

The Telephone Support Program uses Acceptance and Commitment Therapy (ACT) delivered over the phone, which is unique because it focuses on helping patients and caregivers accept difficult emotions and commit to personal values, rather than trying to eliminate symptoms. This approach is novel for advanced gastrointestinal cancer as it addresses both patient and caregiver needs through a convenient, remote format. ^{2 3 5 7 9}

What is the purpose of this trial?

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 education/support Complete a telephone booster session Complete 3 telephone interviews over about 5 months

Research Team

Catherine E Mosher, Ph.D.

Principal Investigator

Indiana University Indianapolis

Eligibility Criteria

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

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

Patient can speak and read English

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

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

2. Germany pubmed.ncbi.nlm.nih.gov

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

3. Netherlands 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy in adult cancer survivors: a systematic review and conceptual model. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Can Acceptance & Commitment Therapy be delivered with fidelity as a brief telephone-intervention? [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Symptom experiences in post-treatment cancer survivors: associations with acceptance and commitment therapy constructs. [2022]

7. England 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. [2023]

8. Scotland pubmed.ncbi.nlm.nih.gov

Efficacy of a self-management program on quality of life in colorectal cancer patients: A randomized controlled trial. [2023]

9. England 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. [2021]