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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01876277
Other study ID # 890-PSY-13
Secondary ID CCR3985
Status Completed
Phase N/A
First received June 10, 2013
Last updated May 20, 2014
Start date June 2013
Est. completion date May 2014

Study information

Verified date May 2014
Source University of Surrey
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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 outÍž

1. What the body image issues are, if any for this group.

2. How any body image issues might affect them, particularly psychologically.

3. 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.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Male
Age group 13 Years to 21 Years
Eligibility Inclusion Criteria:

1. Male- as this research has identified a need for research with this particular group.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

Exclusion Criteria:

- Any participant who did not meet all of the inclusion criteria would be excluded.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Royal Marsden Hopstial Sutton London

Sponsors (2)

Lead Sponsor Collaborator
University of Surrey Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Qualitative Interview Schedule Interview schedule developed by researcher to act as topic guide for interview. 1 hour
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