ReSPECT for Cancer

Overseen By Natasha Frederick, MD, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Connecticut Children's Medical Center

Must be taking: Chemotherapy, Immunotherapy

Disqualifiers: Not on therapy, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve communication between young cancer patients and healthcare providers about sexual and reproductive health. The study tests a new tool called ReSPECT, designed to facilitate these conversations in outpatient oncology settings. It suits adolescents and young adults, aged 15-25, who have cancer, are undergoing treatments like chemotherapy or radiotherapy, and receive care at specific children's hospitals. Participants will complete surveys and interviews to share their experiences with the tool. As an unphased trial, this study offers a unique opportunity to contribute to developing tools that enhance patient-provider communication.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on improving communication about sexual and reproductive health, so it might not require changes to your medication.

What prior data suggests that the ReSPECT intervention is safe for improving AYA-clinician communication?

Research shows that the ReSPECT tool helps young cancer patients discuss reproductive and sexual health with their healthcare providers more easily. As it is neither a drug nor a procedure, it lacks the side effects associated with medications.

In past studies of similar tools, participants found them easy to use and helpful, with no negative effects reported. The ReSPECT tool aims to improve conversations rather than alter medical treatments, making it safe and comfortable for participants.

The trial phase is labeled "Not Applicable," indicating a focus on developing the tool rather than testing physical safety. This further supports the tool's safety for use in studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ReSPECT intervention because it offers a novel approach to cancer treatment by integrating a personalized pre-post design. Unlike traditional cancer therapies that often follow a one-size-fits-all regimen, ReSPECT focuses on tailoring the intervention to individual patient needs and responses. This method not only allows for immediate feedback after the intervention but also tracks patient progress over two months, providing a comprehensive view of its efficacy. This personalized approach has the potential to enhance patient outcomes and improve overall treatment experiences.

What evidence suggests that the ReSPECT intervention is effective for improving AYA-clinician SRH communication?

Research shows that the ReSPECT program aims to enhance communication between young cancer patients and their healthcare providers about sexual and reproductive health. Studies on similar support programs have reported high participation rates, indicating practicality and engagement. Personalized programs like ReSPECT have improved the social and physical quality of life for cancer survivors. By focusing on individual support, ReSPECT could lead to better patient-reported outcomes, with patients feeling more satisfied and understood during their treatment. ^{1 3 6 7 8}

Who Is on the Research Team?

Natasha Frederick, MD, MPH

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

This trial is for adolescent and young adult oncology patients who need better communication with their clinicians about sexual and reproductive health. Specific eligibility criteria are not provided, but typically participants would be within a certain age range and undergoing cancer treatment.

Inclusion Criteria

Provision to sign and date the consent/assent form

Active study participation of primary oncology clinician

Patient must have primary oncology care at Connecticut Children's Center for Cancer & Blood Disorders of Children's Hospital Los Angeles Cancer & Blood Disease Institute

Exclusion Criteria

I am not currently undergoing treatment for cancer.

My doctor thinks I can't fully understand or participate in the study due to cognitive issues.

Unable to speak and read English

Timeline for a Trial Participant

Development and Refinement

Development and refinement of the ReSPECT intervention by integrating feedback from AYAs and pediatric oncology clinicians.

Not specified

Proof-of-Concept Testing

Single-arm cohort study of the ReSPECT intervention using a pre-post design. Participants complete surveys at baseline, immediately after intervention use, and at 2 months from study enrollment.

2 months

3 surveys (baseline, post-intervention, 2 months)

Follow-up

Participants are monitored for the impact of the intervention on SRH communication and related outcomes.

2 months

What Are the Treatments Tested in This Trial?

Interventions

• ReSPECT

Trial Overview The study is testing ReSPECT, an intervention designed to enhance the way young cancer patients and their doctors talk about sexual and reproductive health in outpatient clinics. It's a proof-of-concept trial to see if this tool can improve communication.

How Is the Trial Designed?

Group I: ReSPECT Experimental Treatment 1 Intervention

Aims 2 and 3 involve a single-arm cohort study of the ReSPECT intervention using a pre-post design. Enrolled participants will complete a survey at baseline, immediately after intervention use, and at 2 months from study enrollment. All participants will also be invited to participate in a brief interview immediately after intervention use.

Who Is Running the Clinical Trial?

Connecticut Children's Medical Center

Lead Sponsor

Trials

76

Recruited

30,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9535178/

Person-centred support programme (RESPECT ... Data collection​​ Data were collected from September 2020 to June 2021. Feasibility outcomes were collected during the whole study period by the ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36198470/

Person-centred support programme (RESPECT ... Results: Eighty-six per cent of the patients in the intervention group completed the intervention and questionnaires 3 months after their ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399125000412

Effectiveness of tailored interventions on quality of life in ... Tailored interventions can improve social and physical quality of life and general health in cancer survivors. •. Remote, iterative tailored interventions can ...

4. link.springer.com link.springer.com/article/10.1007/s11764-025-01801-9

Interventions influencing patient-reported outcomes (PROs ... This review summarizes existing literature on interventions employed to improve PROMs response rates in routine practice among patients with cancer.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3832686/

Study protocol: rehabilitation including social and physical ... RESPECT is a multimodal intervention program for children undergoing cancer treatment. This study is an integrated part of a newly established comprehensive ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06470230?locStr=Guatemala&country=Guatemala&rank=10

RESPECT: (REsearching Stigma in PEdiatric Cancer Tool) Researchers want to learn more about the way stigma affects children with cancer and their caregivers. They want to develop two clinical tools.

7. withpower.com withpower.com/trial/respect-for-cancer-86b09

ReSPECT for Cancer This N/A medical study run by Connecticut Children's Medical Center is evaluating whether ReSPECT will have tolerable side effects & efficacy for patients ...

8. researchgate.net researchgate.net/publication/364193611_Person-centred_support_programme_RESPECT_intervention_for_women_with_breast_cancer_treated_with_endocrine_therapy_a_feasibility_study

(PDF) Person-centred support programme (RESPECT ... Results Eighty-six per cent of the patients in the intervention group completed the intervention and questionnaires 3 months after their ...