Educational Interventions for Recovery After Breast Cancer Treatment

KD
SS
Overseen BySheel Singh, MA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: MGH Institute of Health Professions
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best ways to help individuals resume daily activities after completing early-stage breast cancer treatment. It examines different combinations of three methods: identifying personal priorities, providing education, and offering guided support with goal setting and planning. Participants will engage in activities such as phone or video sessions with a coach, focusing on personal recovery goals. This trial suits individuals who completed breast cancer treatment within the past year and struggle to return to their usual work and social activities. As an unphased trial, it provides a unique opportunity to contribute to research that could improve recovery strategies for future patients.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on educational interventions rather than medication changes.

What prior data suggests that these educational interventions are safe for breast cancer recovery?

Research has shown that similar educational programs are generally very safe for participants. Studies on personalized education for breast cancer survivors have found these programs well-tolerated. For instance, programs aimed at improving knowledge and supporting recovery have not reported any serious side effects. Participants often find these programs helpful and effective in enhancing their recovery.

The methods used in this clinical trial, such as helping participants identify what matters most to them and setting goals, draw from techniques successful in past studies. These programs focus on personal support and education, which are usually low risk and considered safe.

Overall, the components used in this trial have a strong safety record, with research indicating they are both beneficial and easy for participants to manage.12345

Why are researchers excited about this trial?

Researchers are excited about these educational interventions for breast cancer recovery because they offer a personalized approach to healing. Unlike standard care, which often focuses on medical treatments like surgery, chemotherapy, or radiation, these interventions prioritize the individual’s personal goals and priorities. Through tailored education and coaching sessions, participants develop customized action plans, making the recovery process more engaging and aligned with their personal needs. This personalized engagement could potentially enhance the overall recovery experience and improve long-term outcomes for breast cancer survivors.

What evidence suggests that this trial's interventions could be effective for promoting activity participation after breast cancer treatment?

This trial will explore various educational interventions to aid recovery after breast cancer treatment. Studies have shown that personalized education and understanding individual priorities can significantly help breast cancer survivors engage in meaningful activities. Specifically, identifying personal priorities appears to enhance involvement. Research indicates that setting goals and creating action plans can improve daily activities. Educational programs, particularly those that consider cultural differences and are interactive, have successfully increased knowledge and self-care among breast cancer survivors. Combining these elements is expected to enhance participation in social and work activities and support overall recovery. Participants in this trial will be assigned to different arms, each focusing on specific combinations of priority elicitation, education, and guided application to evaluate their effectiveness.14678

Who Is on the Research Team?

KD

Kathleen D Lyons, ScD

Principal Investigator

MGH Institute of Health Professions

Are You a Good Fit for This Trial?

This trial is for adults (18+) who have finished treatment for early stage (1-3) breast cancer within the past year, are having trouble returning to work or social activities, and do not have severe mental illness, major depression, substance misuse, significant cognitive problems, hearing loss that can't be fixed, or language barriers.

Inclusion Criteria

Experiencing reduced participation (i.e., a score of > 10 on the Work and Social Adjustment Scale)
I have Stage 1-3 breast cancer and finished treatment within the past year with no recurrence.
I am 18 years old or older.

Exclusion Criteria

I have hearing loss that cannot be corrected.
Moderate-severe cognitive impairment indicated by a score < 3 on a 6-item cognitive screener
History of severe mental illness (i.e., schizophrenia, bipolar disorder), current major depressive disorder, active suicidal ideation, or active substance misuse documented within the medical record
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Optimization Phase

Participants receive one of 8 combinations of intervention components to promote activity participation

20 weeks
Weekly telephone or videoconference sessions

Follow-up

Participants are monitored for satisfaction and ability to participate in social roles and activities

8 weeks
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Individually tailored education, Priority elicitation, Guided application

Trial Overview

The study tests different combinations of education sessions and guided support—like goal setting and problem-solving—to help people after breast cancer get back into daily life activities. Participants will try one of eight possible intervention combinations.

How Is the Trial Designed?

8

Treatment groups

Experimental Treatment

Group I: Priority elicitation, education, and guided applicationExperimental Treatment1 Intervention
Group II: Priority elicitation and guided applicationExperimental Treatment1 Intervention
Group III: Priority elicitation and educationExperimental Treatment1 Intervention
Group IV: Priority elicitationExperimental Treatment1 Intervention
Group V: InformationExperimental Treatment1 Intervention
Group VI: Guided applicationExperimental Treatment1 Intervention
Group VII: Education and guided applicationExperimental Treatment1 Intervention
Group VIII: EducationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

MGH Institute of Health Professions

Lead Sponsor

Trials
19
Recruited
2,200+

University of South Alabama

Collaborator

Trials
44
Recruited
15,800+

Dartmouth-Hitchcock Medical Center

Collaborator

Trials
548
Recruited
2,545,000+

University of Alabama at Birmingham

Collaborator

Trials
1,677
Recruited
2,458,000+

Citations

Optimizing Functional Recovery After Breast Cancer ...

This study will use a factorial experiment to test three intervention components that have been used with breast cancer survivors: (1) priority-elicitation and ...

Evaluating the Effectiveness of a Mobile App for Breast ... - PMC

We aimed to investigate whether a mobile app designed to assist in the self-management of patients with breast cancer is feasible and positively affects their ...

A guided internet-delivered individually-tailored ACT ...

A guided internet-delivered individually-tailored ACT-influenced cognitive behavioural intervention to improve psychosocial outcomes in breast cancer survivors ...

The Comparative Effectiveness of Education Modalities on ...

Background: Educational interventions are central to breast cancer survivorship care, yet adherence may vary depending on delivery modality.

Advancing Survivorship Support Through Virtual Health ...

This study will assess the usability, acceptability, and engagement of participants with the HERCaRE platform, which provides culturally tailored educational ...

A guided internet-delivered individually-tailored ACT ... - PMC

This study will inform on the acceptability, feasibility, efficacy and cost-effectiveness of iNNOVBC, in improving psychosocial outcomes in breast cancer ...

Enhancing Breast Cancer Knowledge Through an ...

The educational program significantly improved BC knowledge among patients and caregivers. These findings highlight the need for structured ...

Efficacy of the Breast Cancer Navigator Role in Reducing ...

The effects of individually tailored nurse navigation for patients with newly diagnosed breast cancer: a randomized pilot study. Acta Oncol. 2017;56:1682 ...