SMSH + TIP-C for Cancer Survivors' Well-being

Recruiting at1 trial location

Overseen by Chris Segrin, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Arizona

Disqualifiers: Psychotic disorder, Bedridden, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a guidebook for managing symptoms and phone counseling for emotional support in cancer survivors and their caregivers, especially those in rural areas. The guidebook offers practical advice, while the counseling helps reduce stress and anxiety.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment SMSH + TIP-C for Cancer Survivors' Well-being?

Research shows that telephone counseling and self-management interventions can improve the quality of life and coping skills for cancer survivors. For example, a study on telephone counseling for breast cancer survivors found it helped with mood, social support, and self-efficacy. Additionally, self-management interventions have been beneficial in helping survivors manage their health and well-being post-treatment. ^{1 2 3 4 5}

Is the SMSH + TIP-C treatment safe for cancer survivors?

The telephone counseling interventions, like those used in the SMSH + TIP-C treatment, have been tested in cancer survivors and are generally considered safe, focusing on improving quality of life and providing psychological support. ^{1 3 4 6 7}

How is the SMSH + TIP-C treatment different from other treatments for cancer survivors?

The SMSH + TIP-C treatment is unique because it combines a handbook for managing symptoms and survivorship with telephone counseling to support cancer survivors' well-being. This approach is novel as it simultaneously addresses both psychosocial and health behavior outcomes through personalized support, which is not commonly found in other treatments. ^{3 4 6 8 9}

Research Team

Chris Segrin, Ph.D.

Principal Investigator

University of Arizona

Eligibility Criteria

This trial is for adult cancer survivors who've finished treatment within the last 2 years and their caregivers. Participants must have telephone access, not be in therapy, be able to do daily tasks, and understand English or Spanish. Caregivers can be of any relation.

Inclusion Criteria

I finished my cancer treatment aimed at curing it between 4 weeks and 2 years ago.

I am aware of the current time, where I am, and who I am.

I can speak and understand either English or Spanish.

Exclusion Criteria

Caregivers: Currently treated for cancer to preserve the distinguishability of 'survivor' and 'caregiver'

I am currently in counseling or psychotherapy.

I am a caregiver and I am under 18.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly phone calls for symptom management and assessment using the General Symptom Management Scale (GSDS) over 16 weeks

16 weeks

16 weekly phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment, including two exit interviews

8 weeks

2 exit interviews at weeks 17 and 24

Treatment Details

Interventions

• Adaptive Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C) (Behavioral Intervention)
• NCI Brochure (Behavioral Intervention)

Trial Overview The study tests two phone-based supports: a Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C), compared with receiving an NCI brochure on managing post-treatment needs.

Participant Groups

Group I: Intervention Arm Experimental Treatment 1 Intervention

Adaptive Need-based Sequence

Group II: Attention control Active Control 1 Intervention

This group will be participants that were randomized to the "Attention control" arm and will not receive the SMSH + TIP-C adaptive intervention.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Dr. Richard Carmona

University of Arizona

Chief Medical Officer since 2021

MD, University of Arizona

Dr. Evan Unger

University of Arizona

Chief Executive Officer since 2021

PhD in Medical Imaging, University of Arizona

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Dr. Larry Weiss

American Cancer Society, Inc.

Chief Medical Officer since 2016

MD from Duke University Medical Center

Dr. Wayne A. I. Frederick

American Cancer Society, Inc.

Chief Executive Officer

MD from Howard University, MBA from Howard University

Findings from Research

A communication skills training (CST) workshop for 19 oncologists significantly improved their ability to discuss survivorship care plans with lymphoma survivors, as evidenced by enhanced scores in six out of seven assessment categories.

The training not only increased the oncologists' use of survivorship care plans but also boosted their confidence in discussing long-term effects and health maintenance recommendations with patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship care planning after participation in communication skills training intervention for a consultation about lymphoma survivorship. Banerjee, SC., Matasar, MJ., Bylund, CL., et al.[2018]

A 4-week self-management intervention for breast cancer survivors led to positive experiences and increased self-efficacy, with benefits reported even two years later by the 21 participants in the study.

Despite the success of the program in fostering community and self-management skills, a significant gap was identified in bereavement support for women who lost friends, highlighting the need for comprehensive emotional support in survivorship care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative experiences of breast cancer survivors on a self-management intervention: 2-year post-intervention. Loh, SY., Ong, L., Ng, LL., et al.[2017]

The C-STEPS telephone counseling program, involving 66 cancer survivors, effectively reduced cancer-specific distress and improved physical activity levels, demonstrating its feasibility and potential benefits for survivors post-treatment.

Participants reported high satisfaction with the program (9 out of 10) and showed increased fruit and vegetable consumption, particularly among those who attended nutrition and exercise sessions, indicating positive lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the transition from cancer patient to survivor: pilot study results of the Cancer Survivor Telephone Education and Personal Support (C-STEPS) program. Garrett, K., Okuyama, S., Jones, W., et al.[2021]

The Telephone Counseling Trial for Breast Cancer Survivors aims to improve the quality of life for 400 early-stage breast cancer patients through a structured telephone-based counseling intervention over 12 months, focusing on coping strategies and psychological support.

The study will assess various outcomes, including mood and self-efficacy, at multiple follow-up points (3, 6, 12, and 18 months), potentially establishing a model for future psychosocial interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone counseling of breast cancer patients after treatment: a description of a randomized clinical trial. Marcus, AC., Garrett, KM., Cella, D., et al.[2007]

The Survivorship Consult (SC) program significantly improved the experience of 26 breast cancer survivors by fostering supportive dialogue with care clinicians, which enhanced their understanding of their health and treatment options.

Participants reported increased confidence in managing their care and were motivated to set personalized health goals, indicating that the SC effectively empowers survivors in their post-diagnosis journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the use of the survivorship consult in providing survivorship care. Wiljer, D., Urowitz, S., Jones, J., et al.[2021]

The C-STEPS program is the first telephone counseling intervention designed specifically for cancer survivors, focusing on both psychosocial support and health behavior outcomes.

This pilot study aimed to assess the feasibility of implementing this program, highlighting its potential to improve the well-being of cancer survivors through accessible support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship care plans. Behrend, SW.[2014]

Cancer survivorship care plans (SCPs) are generally supported by stakeholders, including survivors and healthcare providers, but there is a lack of personal experience with them, indicating a gap in implementation.

Key themes for improving SCPs include the need for clear roles in their use, tailored content for different audiences, streamlined documentation processes, and the idea of SCPs as 'living documents' to enhance coordination of care, especially for head and neck cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Key Stakeholders' Knowledge, Needs, and Preferences for Head and Neck Cancer Survivorship Care Plans. Zullig, LL., Ramos, K., Berkowitz, C., et al.[2021]

The Kanker Nazorg Wijzer (KNW) self-management intervention was well-received by early cancer survivors, with 98.3% of participants referred to modules and 85.7% visiting at least one module, indicating high engagement with the program.

Participants who received personalized module referral advice were more likely to use the recommended modules, suggesting that tailored guidance enhances the effectiveness of the intervention in supporting cancer survivors' psychosocial needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use and Appreciation of a Tailored Self-Management eHealth Intervention for Early Cancer Survivors: Process Evaluation of a Randomized Controlled Trial. Kanera, IM., Willems, RA., Bolman, CA., et al.[2018]

A study of 673 female cancer survivors revealed that while strategies like complementary and alternative medicine (CAM) and exercise are commonly assessed, their frequent use is low (<10%), suggesting that reliance on these strategies may be overestimated.

The research identified five key categories of self-management, with 'Turning to Family/Friends' and 'More Conscious Living' being the most frequently employed strategies, indicating that social support and mindfulness may be more significant for cancer survivors than traditional methods like CAM or exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and frequency of self-management strategies among female cancer survivors: the neglected roles of social relations and conscious living. Sieverding, M., Ungar, N., Fleischmann, A., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Survivorship care planning after participation in communication skills training intervention for a consultation about lymphoma survivorship. [2018]

2. Thailand pubmed.ncbi.nlm.nih.gov

Qualitative experiences of breast cancer survivors on a self-management intervention: 2-year post-intervention. [2017]

3. Ireland pubmed.ncbi.nlm.nih.gov

Bridging the transition from cancer patient to survivor: pilot study results of the Cancer Survivor Telephone Education and Personal Support (C-STEPS) program. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Telephone counseling of breast cancer patients after treatment: a description of a randomized clinical trial. [2007]

5. Germany pubmed.ncbi.nlm.nih.gov

Exploring the use of the survivorship consult in providing survivorship care. [2021]

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

Survivorship care plans. [2014]

7. England pubmed.ncbi.nlm.nih.gov

Assessing Key Stakeholders' Knowledge, Needs, and Preferences for Head and Neck Cancer Survivorship Care Plans. [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

Use and Appreciation of a Tailored Self-Management eHealth Intervention for Early Cancer Survivors: Process Evaluation of a Randomized Controlled Trial. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

Prevalence and frequency of self-management strategies among female cancer survivors: the neglected roles of social relations and conscious living. [2020]