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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
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
Study Summary
This trial is testing whether the SMSH and TIP-C interventions can improve cancer survivors’ and caregivers’ physical and psychological symptoms and quality of life.
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.Check my eligibility
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.See study design
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.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Depression and Anxiety of Survivors' and Caregivers'
Change in Number and Distressed Associated with Survivors' and Caregivers' Symptoms
Secondary outcome measures
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
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.
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Who is running the clinical trial?
University of ArizonaLead Sponsor
512 Previous Clinical Trials
147,589 Total Patients Enrolled
3 Trials studying Cancer Survivors
286 Patients Enrolled for Cancer Survivors
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,245 Total Patients Enrolled
1 Trials studying Cancer Survivors
217 Patients Enrolled for Cancer Survivors
Chris Segrin, Ph.D.Principal InvestigatorUniversity of Arizona
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am currently in counseling or psychotherapy.I am a caregiver and I am 18 years old or older.I, as a caregiver, can speak and understand English or Spanish.I am a caregiver and I am under 18.I am currently receiving counseling or psychotherapy.I am under 18 years old.I can perform daily tasks like eating and dressing by myself.I am 18 years old or older.I live in a nursing home.I am bedridden.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Arm
- Group 2: Attention control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings currently available for enrolment in this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this medical trial which was initially posted on August 22nd 2022 is actively seeking participants. 212 individuals need to be enrolled from one single site for the study's completion."
Answered by AI
What is the scope of recruitment for this trial?
"Affirmative. Clinicaltrials.gov states that the recruitment phase of this trial is active, with a posting date on August 22nd 2022 and most recent update on September 2nd 2022. Currently, 212 participants are being sought for this study at one medical centre."
Answered by AI
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