NCT06152926

Brief Summary

People who are diagnosed with a cancer commonly experience symptoms that affect day-to-day life, including muscle weakness, pain, tiredness and fatigue. These consequences can make it hard for people to tolerate their medical treatments. It is well known that regular physical activity or planned exercise can help with these symptoms and significantly improve physical and mental health during cancer treatment. Recent animal studies suggest that exercise training can also reduce the number of cancer cells. For example, exercise training in mice produces more immune cells in the tumour. These immune cells in the tumour contribute to the destruction and reduction of the size of the tumour and are a vital component of effective immunotherapy (cancer treatment that helps your immune system fight cancer). In humans, exercise training and the effect on the immune response in tumours are less understood and is a new area being explored. However, we are aware that most people diagnosed with a cancer are not physically active, and especially not during the treatment period. The aim of this study is to understand the experiences and perceptions of physical activity and exercise in those with cancer receiving immunotherapy treatment (such as immune check point inhibitors (ICI). This will help us to create new practices or change practices to help those with cancer to partake in physical activity and exercise when on treatment. Participants consenting to take part in the study will be individually interviewed through a semi-structured interview.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 1, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

December 4, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

November 22, 2023

Last Update Submit

November 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Exploration of experiences

    To understand participant's perspectives and experiences of physical activity and exercise on immune check point immunotherapy treatment through Inductive thematic analysis of semi-structured individual interviews.

    3-6 months

Interventions

People diagnosed with a urological cancer receiving Immune checkpoint inhibitor treatment at a single centre trust will be invited to either face to face or online video-conference individual interviews (Microsoft teams) according to participant preference. Consenting participants will be interviewed via semi-structured interview methods round a topic guide and audio-recorded. Inductive thematic analysis will be conducted to explore participant experiences and perceptions of physical activity and exercise.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with a urological cancer (Bladder or Renal) that are receiving or planned to receive immunotherapy treatment (with immune check point inhibitors) at a single centre.

You may qualify if:

  • Primary Urological (Bladder and Renal) cancer diagnosis receiving or planned immune check point inhibitor treatment at GSTT hospital.
  • Adults aged 18 years or older
  • Willing and able to take part in Face to Face interviews at a hospital site or virtual video interviews at home.
  • Cancer survival \>6 month
  • Proficient in English

You may not qualify if:

  • Aged lower than 18 years
  • Inability to give informed consent and information (due to unable to speak or understand English)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Handford J, Chen M, Rai R, Moss CL, Enting D, Peat N, Karagiannis SN, Van Hemelrijck M, Russell B. Is There a Role for Exercise When Treating Patients with Cancer with Immune Checkpoint Inhibitors? A Scoping Review. Cancers (Basel). 2022 Oct 14;14(20):5039. doi: 10.3390/cancers14205039.

MeSH Terms

Conditions

Neoplasms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mieke Van-Helmerijk

    King's College London

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Physiotherapist

Study Record Dates

First Submitted

November 22, 2023

First Posted

December 1, 2023

Study Start

December 4, 2023

Primary Completion

January 31, 2024

Study Completion

June 30, 2024

Last Updated

December 1, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be disclosed to any other researchers. Participant data from the study will be anonymised and reported within a report for researchers and the general public to review as a peer review report.