Intervention Arm for Malignancies

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Arizona, Tucson, AZ
Malignancies+3 More
Adaptive Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C) - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

As the population of cancer survivors increases substantially, meeting the health care and psychosocial needs of this population has become a national priority. After treatment ends, cancer survivors still experience a range of physical and psychological symptoms that require management. The post-treatment period can present new challenges for many survivors as they encounter communication gaps in the transition from oncology to primary care, leaving unmet needs for information and management of lingering symptoms. The role of informal caregivers remains important during this post-treatment period and psychosocial interventions that meet the needs (e.g., information, symptom management) of both members of the dyad are highly valuable to caregivers and survivors. Many geographic and social determinants of health care use (e.g., distance to specialty care centers, available primary care providers, and public transportation) make access to care and adherence to recommended healthcare guidelines difficult for survivors and caregivers, especially those who reside in rural areas. Rural residents with cancer and their caregivers during the post-treatment period are underrepresented in symptom management research. To address the unmet needs (e.g., information, symptom management) of cancer survivors and their caregivers after cancer treatment, this team has developed, tested, and investigated two telephone delivered interventions for survivors and their caregivers: Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C).

Eligible Conditions

  • Malignancies
  • Cancer Survivors
  • Psychological Distress
  • Informal Caregivers

Treatment Effectiveness

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: The GSDS will be captured at baseline, during the 16 weekly calls and during the two exit interviews at weeks 17 and 24.

Week 17
Change in Number and Distressed Associated with Survivors' and Caregivers' Symptoms
Week 17
Change in Depression and Anxiety of Survivors' and Caregivers'
Week 24
Change in Survivors' and Caregivers' health services use: Unscheduled and scheduled visits
Week 24
Survivors' and Caregivers' health services use: The American Society of Clinical Oncology Survivorship Guidelines

Trial Safety

Trial Design

2 Treatment Groups

Attention control
1 of 2
Intervention Arm
1 of 2
Active Control
Experimental Treatment

212 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention Arm · No Placebo Group · N/A

Intervention Arm
Behavioral
Experimental Group · 1 Intervention: Adaptive Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C) · Intervention Types: Behavioral
Attention control
Behavioral
ActiveComparator Group · 1 Intervention: NCI Brochure · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: the gsds will be captured at baseline, during the 16 weekly calls and during the two exit interviews at weeks 17 and 24.
Closest Location: University of Arizona · Tucson, AZ
Photo of az university of arizona  1Photo of az university of arizona  2Photo of tucson  3
2002First Recorded Clinical Trial
6 TrialsResearching Malignancies
240 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have cancer and you have completed or completed cancer treatment with curative intent.
You have a caregiver who can be any relationship role (e.g.
You are intellectually oriented to time, place, and person.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.