CancerNCT01876277
Body Image Issues in Boys Being Treated at the Royal Marsden
An observational study of Cancer, run by University of Surrey at 1 site in United Kingdom.
Trial summary
In adolescence, the effects of cancer and its treatment can lead to bodily changes such as hair loss, weight loss or gain, amputations, scars and developmental delay. As treatments for childhood cancers improve and life expectancy increases, more adolescents have to deal with the effects of cancer and the treatment on… Read more about this study
- Who is it for?
- Ages 13 to 21 years, men only
- Conditions the study is for
- Cancer
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2013to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 21 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: Adolescent males who have been treated for cancer at the Royal Marsden Hospital within the past 5 years.
Who may be able to join
- Male- as this research has identified a need for research with this particular group.
- Aged between 13 and 21 (inclusive)as this research is focussing on adolescents and we have defined the age range of adolescence as 13 to 21, in line with other research on adolescence.
- Have a diagnosis of cancer (any type)as this study is not focussing on any particular type of cancer and this will ensure a sufficient pool of participants.
- Have been diagnosed for at least 6 months as issues about adjusting to the diagnosis will be less prevalent at this time and they are likely to have received some treatment for cancer which often produces some of the bodily changes that may affect their body image.
- Have a prognosis of more than 3 months, as it would be unethical to interview people in the final stages of terminal cancer as end of life issues would be more prevalent. Three months was decided upon because often this is the length of time given to patients when it is decided that treatment is no longer indicated and their illness is considered terminal. We would not contact anyone whose cancer was considered terminal.
- Have had treatment within the past 5 years, because beyond this time they are less likely to have body image issues and other issues or than cancer could be more prevalent for them, so they are not suitable participants.
- Able to participate in the interview verbally and in English because the qualitative method requires detailed analysis of the texts and translation may lead to a loss in some of the meaning that is crucial for this research.
Who cannot join
- Any participant who did not meet all of the inclusion criteria would be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: What Are the Psychosocial Implications of Body Image Issues in Adolescent Males With Cancer?
In adolescence, the effects of cancer and its treatment can lead to bodily changes such as hair loss, weight loss or gain, amputations, scars and developmental delay. As treatments for childhood cancers improve and life expectancy increases, more adolescents have to deal with the effects of cancer and the treatment on their bodies throughout their lives.
Body image can be defined as "The mental image we hold of our bodies". There are two aspects to this, how we "see" our size/shape/weight etc, and then how we feel about this. Often the actual change in body does not always predict how people cope with it, or how they feel about it.
Read more
Prior research suggests, and clinical experiences suggests that body image issues arise for at least some adolescents with cancer, however it is unknown whether a disturbance in body image is seen as distressing for the adolescent, or how this affects them psychologically.
Body image problems were always seen as a typically female problem, and therefore researchers have often neglected to look at the issues for men. There is currently no research specifically addressing the impact of body image in adolescent boys with cancer.
This research will involve interviewing adolescent males with cancer with the aims to find out;
- What the body image issues are, if any for this group.
- How any body image issues might affect them, particularly psychologically.
- What helps or hinders this group maintain a positive body image, or stop it having a negative impact on them psychologically.
It is hoped that this will help to inform psychological treatments for body image difficulties in the future.
- Conditions
- Cancer
- Keywords
- Cancer, Body image, Adolescent
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent males with cancer | Males aged 13-21 who have been treated at the Royal Marsden Hospital for cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Interview Schedule
Interview schedule developed by researcher to act as topic guide for interview.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Annabel Christopher, BSc, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876277
- Sponsor's protocol ID
- 890-PSY-13
- Other IDs
- CCR3985
- Status last verified
- Jul 2024
- First submitted
- 10 Jun 2013
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Psychosocial Implications of Body Image Issues in Adolescent Males With Cancer?
- ClinicalTrials.gov ID
- NCT01876277
- Acronym / sponsor ID
- 890-PSY-13
- Conditions
- Cancer
- Keywords
- Cancer, Body image, Adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Study start
- Jun 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In adolescence, the effects of cancer and its treatment can lead to bodily changes such as hair loss, weight loss or gain, amputations, scars and developmental delay. As treatments for childhood cancers improve and life expectancy increases, more adolescents have to deal with the effects of cancer and the treatment on their bodies throughout their lives.
Body image can be defined as "The mental image we hold of our bodies". There are two aspects to this, how we "see" our size/shape/weight etc, and then how we feel about this. Often the actual change in body does not always predict how people cope with it, or how they feel about it.
Prior research suggests, and clinical experiences suggests that body image issues arise for at least some adolescents with cancer, however it is unknown whether a disturbance in body image is seen as distressing for the adolescent, or how this affects them psychologically.
Body image problems were always seen as a typically female problem, and therefore researchers have often neglected to look at the issues for men. There is currently no research specifically addressing the impact of body image in adolescent boys with cancer.
This research will involve interviewing adolescent males with cancer with the aims to find out;
- What the body image issues are, if any for this group.
- How any body image issues might affect them, particularly psychologically.
- What helps or hinders this group maintain a positive body image, or stop it having a negative impact on them psychologically.
It is hoped that this will help to inform psychological treatments for body image difficulties in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent males with cancer | – | –Males aged 13-21 who have been treated at the Royal Marsden Hospital for cancer. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescent males who have been treated for cancer at the Royal Marsden Hospital within the past 5 years.
Key inclusion criteria (7 listed)
- Male- as this research has identified a need for research with this particular group.
- Aged between 13 and 21 (inclusive)as this research is focussing on adolescents and we have defined the age range of adolescence as 13 to 21, in line with other research on adolescence.
- Have a diagnosis of cancer (any type)as this study is not focussing on any particular type of cancer and this will ensure a sufficient pool of participants.
- Have been diagnosed for at least 6 months as issues about adjusting to the diagnosis will be less prevalent at this time and they are likely to have received some treatment for cancer which often produces some of the bodily changes that may affect their body image.
- Have a prognosis of more than 3 months, as it would be unethical to interview people in the final stages of terminal cancer as end of life issues would be more prevalent. Three months was decided upon because often this is the length of time given to patients when it is decided that treatment is no longer indicated and their illness is considered terminal. We would not contact anyone whose cancer was considered terminal.
Key exclusion criteria (1 listed)
- Any participant who did not meet all of the inclusion criteria would be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative Interview Schedule
Time frame: 1 hour
Interview schedule developed by researcher to act as topic guide for interview.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annabel Christopher, BSc principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Interview Schedule (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.