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Behavioral Intervention

Together After Cancer Program for Breast Cancer

N/A

Recruiting

Research Sponsored by University of South Florida

Eligibility Criteria Checklist

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

Must have

Be 18 years of age and older

Primary diagnosis of breast cancer in the last five years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2, 5 month

Awards & highlights

Study Summary

This trial tests a new online program to help couples affected by breast cancer, with optional coach calls. Results will be compared with usual care.

Who is the study for?

This trial is for Latina/Hispanic breast cancer survivors, aged 18+, who've finished initial treatment within the last five years. Participants must be in a committed relationship for at least six months, willing to follow the study for about 5 months, and have internet access. They must reside in Florida.Check my eligibility

What is being tested?

The trial tests an online self-help program called 'Together After Cancer,' which includes brief coaching calls, versus usual care. Couples are randomly assigned to either group and evaluated at the start, after completing the program, and three months post-randomization.See study design

What are the potential side effects?

Since this intervention involves an online program with coach support rather than medication or medical procedures, traditional side effects are not applicable. However, participants may experience emotional or psychological responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I was diagnosed with breast cancer within the last 5 years.

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I have finished my first round of treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2, 5 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2, 5 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2, 5 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate the changes in the quality of life of the breast cancer survivor across the pre to post to follow-up measurement time points.

Evaluate the changes in the satisfaction of the relationship between couples who are married across the pre to post to follow-up measurement time points.

Secondary outcome measures

Evaluate changes in emotional distress-anxiety among breast cancer survivors and their intimate partner across the pre to post to follow-up measurement time points.

Evaluate changes in emotional distress-depression among breast cancer survivor and their intimate partner across the pre to post to follow-up measurement time points.

Evaluate changes in feeling cared and valued as a person among breast cancer survivors and their intimate partner across the pre to post to follow-up measurement time points.

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Together After Cancer InterventionExperimental Treatment1 Intervention

Couples randomized into the intervention will participate in the program which is approximately 8-10 hours of web-based online content to be delivered over the course of 5-8 weeks. The online program can be done on a smartphone, tablet, or computer. In this program, partners complete the majority of the program on their own (to make it more flexible) and come together for 2-3 key conversations with their partner. In addition to the online content, couples will receive up to 100 minutes of scheduled research check-in/coaching calls from a research assistant to check-in. These coach calls will occur via a video chat via Zoom or, if not possible given a couple's technology limitations, over the phone. The coach calls serve several purposes: a) helping couples stay accountable to staying on the recommended schedule of activity completion; b) addressing any technical or program questions the couple has; and c) collecting research data as couples move through the program.

Group II: Usual CareActive Control1 Intervention

Participants randomized into UC, will consist of primary referral sources for breast cancer survivorship. At AdventHealth, Moffitt, and Sylvester Cancer centers, usual care consists of screening items assessing relationship/intimacy issues as a practical need. If these items are endorsed, referrals are provided to supportive oncology. At Sylvester, the Cancer Support Services offers caregiver support groups, "mental well-being" services (i.e., individual therapy), and an online support community for patients, caregivers, and survivors. At Moffitt, Support Services offers psychotherapy, support groups for patients, support groups for family/caregivers of cancer patients, and a program to help patients talk with their children about their diagnosis. At AdventHealth, patients are offered referrals to social services and psychoeducational programs like HEAL. However, none of the sites have services designed to focus on issues specific to patients' romantic relationships.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Central FloridaOTHER

79 Previous Clinical Trials

1,097,880 Total Patients Enrolled

University of Miami Sylvester Comprehensive Cancer CenterOTHER

9 Previous Clinical Trials

2,139 Total Patients Enrolled

AdventHealthOTHER

107 Previous Clinical Trials

29,099 Total Patients Enrolled

Media Library

Together After Cancer (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05645471 — N/A

Communication Research Study Groups: Together After Cancer Intervention, Usual Care

Communication Clinical Trial 2023: Together After Cancer Highlights & Side Effects. Trial Name: NCT05645471 — N/A

Together After Cancer (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05645471 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial permit applicants older than 30 to participate?

"This medical trial is recruiting participants between the ages of 18 and 80. For those outside this age range, there are 120 studies catering to minors aged below 18 and 2,741 trials serving seniors above 65 years old."

Answered by AI

How many volunteers have been recruited to participate in this trial?

"Affirmative, based on the information hosted by clinicaltrials.gov it appears that this medical project is actively enrolling candidates. This trial debuted on January 1st 2023 and was last updated on April 6th of the same year; currently they are looking to register 480 participants across 2 distinct locations."

Answered by AI

Is the enrolment period for this research still ongoing?

"Affirmative. Clinicaltrials.gov has the most recent data which confirms that this trial, first posted on 1st January 2023, is actively searching for participants. A total of 480 individuals need to be recruited from 2 sites."

Answered by AI

Do I meet the qualifications for involvement in this research project?

"This clinical study is taking in 480 individuals, aged between 18 and 80 years old, who have experienced a diagnosis of breast cancer within the past five years. To be eligible to take part, participants must further meet specific criteria including: self-identifying as Latinx/Hispanic; being bilingual in Spanish; having completed their initial treatment for breast cancer; participating in an intimate relationship that has lasted at least six months or longer with another Latina Breast Cancer Survivor diagnosed within the last five years; possessing access to electronic devices such as phones, computers and tablets connected to internet services; agreeing to partake voluntary randomization procedures followed by 5 months of monitoring"

Answered by AI

What is the primary goal of this research project?

"This clinical trial seeks to gauge the impact of an intervention on couples' relationship satisfaction over a Baseline, 2 and 5 month period. Secondary objectives include assessing emotional distress-anxiety (PROMIS: Emotional Distress - Anxiety; α=0.96), body image perception (Body Image Scale; α=.90) and sense of being cared for and valued as a person (PROMIS: Emotional Support; α=0.98)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Together After Cancer

Dinorah Martinez Tyson, PhD, MPH, MA 2023. "Together After Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05645471.

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