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

Not currently recruiting at 1 trial location

Overseen By Beatriz Rodriguez-Aldridge

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Psychotic disorder, Bedridden, others

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

Compensation: Varies

Number of Visits: 18

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help cancer survivors and their caregivers manage lingering symptoms and fill information gaps after treatment. It tests two phone-based programs: a Symptom Management Handbook and Telephone Counseling, designed to support both survivors and their caregivers. The trial seeks cancer survivors who completed treatment within the last two years and have a caregiver who can join them.

As an unphased trial, this study offers a unique opportunity for participants to contribute to valuable research that could enhance post-treatment support for others.

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 prior data suggests that these interventions are safe for cancer survivors and their caregivers?

Research has shown that both the Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C) are user-friendly for participants. Studies have found that these phone-based programs assist in managing symptoms and offer emotional support for cancer survivors and their caregivers. The available research reports no serious side effects from these treatments. Participants receive weekly phone calls, which effectively help them manage ongoing symptoms and address emotional needs. Overall, these methods appear safe and beneficial for the well-being of cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SMSH and TIP-C for cancer survivors' well-being because these approaches focus on personalized, adaptive support rather than just medical treatment. Unlike traditional methods that might focus solely on medication or standard counseling sessions, SMSH provides a tailored handbook that evolves to meet individual survivors' needs. TIP-C adds a unique layer by offering interpersonal counseling over the phone, making mental health support more accessible and flexible for patients who may be dealing with the lingering effects of cancer treatment. Together, these interventions aim to holistically enhance the quality of life for survivors, addressing both physical and emotional challenges in a personalized way.

What evidence suggests that SMSH + TIP-C is effective for cancer survivors' well-being?

Research has shown that using the Symptom Management and Survivorship Handbook (SMSH) along with Telephone Interpersonal Counseling (TIP-C) can help cancer survivors feel less stressed. Participants in the intervention arm of this trial will receive these resources. Studies have also found that this method can reduce the severity of symptoms often experienced after cancer treatment. In a previous study with 66 cancer survivors, this type of phone counseling effectively lowered cancer-related stress and increased physical activity. The SMSH is based on a successful Symptom Management Toolkit used in earlier research. Overall, these methods aim to improve the well-being of cancer survivors during the challenging period following treatment. ^{1 3 4 5 6}

Who Is on the Research Team?

Chris Segrin, Ph.D.

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Published Research Related to This Trial

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]

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]

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 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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05360498

Symptom Management for Rural-Urban Cancer Survivors ... SMSH+TIP-C will result in lower psychological distress and summed severity index of 14 other symptoms (primary outcomes) over weeks 1-17 and 24, more ...

2. withpower.com withpower.com/trial/phase-cancer-survivors-5-2022-eb0dc

SMSH + TIP-C for Cancer Survivors' Well-being The C-STEPS telephone counseling program, involving 66 cancer survivors, effectively reduced cancer-specific distress and improved physical activity levels, ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-04101&loc=0&ni=10&pn=527&rl=1

Need-based Adaptive Symptom Management for ... This clinical trial tests the potential benefits of two therapies designed to relieve symptoms experienced by cancer survivors and their caregivers.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10192117/

A sequential multiple assignment randomized trial ... Interventions · Symptom Management and Survivorship Handbook is an evidence-based guide adapted from the Symptom Management Toolkit used in previous studies.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885392423000696

A Sequential Multiple Assignment Randomized Trial of ... The purpose of this study was to test optimal sequencing of two evidence-based interventions for symptom management after completion of cancer treatment.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39612086/

Symptom management interventions influence unscheduled ... Purpose: Three sequences of telephone symptom management interventions were tested on use of unscheduled health services among cancer survivors ...