The Improving Cancer Aftercare Study.

NCT04163068 | Completed

• 1 other identifier: 2-078-19
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This is a qualitative interview study that aims to understand treatment burden in individuals who have experienced prostate or colorectal cancer treatment within the past five years. We intend to use patient and caregiver experiences to co-design interventions to optimise cancer aftercare. Treatment burden is the workload of healthcare for patients and the consequences of this workload on patient function. Treatment burden has been associated with negative outcomes in stroke, heart failure, diabetes, and renal failure. Cancer is increasingly becoming a chronic condition, and involves a variety of self-management tasks for patients and their caregivers. In this study investigators will investigate treatment burden in people after prostate and colorectal cancer. Investigators will seek to understand patient and caregiver perceptions about cancer aftercare, and ways that services could be redesigned and improved to reduce treatment burden, and improve patient outcomes. We will undertake a qualitative interview study, recruiting patients from general practices and oncology outpatient clinics who have completed potentially curative treatment for prostate or colorectal cancer, or who are on active surveillance or hormonal therapies for localised or locally advanced prostate cancer. We will purposively sample, to ensure that participants with comorbidities, those from lower socioeconomic groups, and rural dwellers are adequately represented. We will conduct interviews according to a schedule, informed by conceptual models of burden of treatment, Schwarzer's Health Action Process Approach, and Normalisation Process Theory. Interviews will be filmed and/or audio-recorded and transcribed. Framework and thematic analysis will be used to analyse and synthesise the data. Participants will be given the chance to comment on outputs and findings (triangulation). Investigators plan to use the results of this study, and excerpts from video interviews during co-design events, and to create new interventions to optimise aftercare for patients with prostate and colorectal cancer.

Conditions

Colorectal Cancer; Prostate Cancer

Keywords

cancer; survivorship; qualitative interviews; treatment burden; cancer aftercare; self management

Outcome Measures

Primary Outcomes (1)

• Treatment burden

  Patient and caregiver perceptions of treatment burden assessed through semi-structured interviews and analysed by Framework and thematic analysis.

  12 months

Study Arms (1)

Interview with researcher

All participants will participate in an interview with a researcher

Other: Interview

Interventions

Interview OTHER

The interview will last approximately 45 minutes, will be audio-recorded, transcribed, and analysed

Interview with researcher

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult survivors of prostate or colorectal cancer and their caregivers.

You may qualify if:

• Individuals who have a history of prostate or colorectal cancer within the past five years (we are interested in recent experiences and most individuals with colorectal cancer are discharged by five years from hospital follow up)
• Individuals who have or have had localised or locally advanced disease, treated by any method, including and not limited to active surveillance, surgery, radiotherapy, or chemotherapy.
• Adult age 18 years or over
• Caregivers for an individual who meets the above criteria, who are aged 18 years or over.

You may not qualify if:

• Individuals who do not wish to participate
• Individuals who do not understand and/or speak English
• Individuals with significant cognitive impairment, learning difficulty, or communication difficulty such that understanding the nature of the study, the interview questions, or participating in an interview would not be practical
• Presence of distant metastases at the time of recruitment, which are being treated with palliative intent (treatment and follow up for these individuals has different aims and format)
• Individuals who are currently undergoing or on waiting lists for chemotherapy, radiotherapy, or surgery (for their colorectal or prostate cancer)
• Caregivers who do not have a linked patient participant

Sponsors & Collaborators

• University of Aberdeen: lead
• NHS Grampian: collaborator

Study Sites (1)

University of Aberdeen

Aberdeen, UK, AB25 2ZD, United Kingdom

Location

Related Publications (1)

• Adam R, Duncan L, Maclennan SJ, Locock L. Treatment burden in survivors of prostate and colorectal cancers: a qualitative interview study. BMJ Open. 2023 Mar 3;13(3):e068997. doi: 10.1136/bmjopen-2022-068997.

  PMID: 36868591 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Prostatic Neoplasms; Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rosalind Adam

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 14, 2019
• Study Start: January 8, 2020
• Primary Completion: November 4, 2021
• Study Completion: November 4, 2021
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)