What side effects are associated with this type of intervention?

Cancer survivors often experience a range of side effects post-treatment, including fatigue, pain, psychological distress (such as anxiety and depression), and cognitive difficulties. Other common issues include sleep disturbances, gastrointestinal problems, and lymphedema. Treatments like the Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C) focus on providing information and symptom management support via telephone to help address these challenges and improve the quality of life for survivors.

What prior FDA approvals exist?

The FDA has approved various treatments for cancer survivors that focus on symptom management and support. While specific telephone-based interventions like the Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C) are not directly mentioned, the FDA has approved several drugs and therapies aimed at managing symptoms such as pain, nausea, and neuropathy. These include medications like antiemetics for nausea, analgesics for pain, and topical treatments for neuropathy. Additionally, the FDA supports the use of integrative therapies, such as acupuncture and reflexology, which have shown efficacy in managing cancer-related symptoms. These treatments align with the goals of providing comprehensive symptom management and support for cancer survivors.

What other types of research exist?

Promising alternatives to SMSH and TIP-C for cancer survivors include: 1) Electronic patient-reported outcomes (ePROs) combined with sensor-enabled vital signs capture, as explored in a feasibility pilot study for outpatient symptom management. 2) Online Symptom Care and Management Systems (SCMS) that allow patients to record and send daily symptom data for remote monitoring and support. 3) Integrative therapies such as music therapy, meditation, and yoga, which have shown benefits for anxiety, stress, and mood disorders in cancer patients.

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

N/A

Recruiting

Led By Chris Segrin, Ph.D.

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Caregivers: Less than 18 years of age

Survivors: Less than 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the gsds will be captured at baseline, during the 16 weekly calls and during the two exit interviews at weeks 17 and 24.

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves informational handbooks and counseling over the phone rather than medication, there are no direct medical side effects. However, discussing sensitive topics might cause emotional discomfort.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a caregiver and I am under 18.

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I am under 18 years old.

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I live in a nursing home.

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I am bedridden.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the gsds will be captured at baseline, during the 16 weekly calls and during the two exit interviews at weeks 17 and 24.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the gsds will be captured at baseline, during the 16 weekly calls and during the two exit interviews at weeks 17 and 24.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the gsds will be captured at baseline, during the 16 weekly calls and during the two exit interviews at weeks 17 and 24. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Depression and Anxiety of Survivors' and Caregivers'

Change in Number and Distressed Associated with Survivors' and Caregivers' Symptoms

Secondary study objectives

Change in Survivors' and Caregivers' health services use: Unscheduled and scheduled visits

Survivors' and Caregivers' health services use: The American Society of Clinical Oncology Survivorship Guidelines

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment1 Intervention

Adaptive Need-based Sequence

Group II: Attention controlActive Control1 Intervention

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C) are interventions designed to support cancer survivors by providing information and managing symptoms via telephone. These treatments work by addressing the physical and psychological symptoms that persist after cancer treatment, offering continuous support and guidance. This approach is crucial for cancer survivors as it helps bridge the communication gap between oncology and primary care, ensuring that survivors receive consistent care and support, which can significantly improve their quality of life and overall well-being.

A Multi-step Approach to Adapting a Mind-Body Resiliency Intervention for Fear of Cancer Recurrence and Uncertainty in Survivorship (IN FOCUS).Rationale and Design of a Telehealth Self-Management, Shared Care Intervention for Post-treatment Survivors of Lung and Colorectal Cancer.