Breast Cancer Cancer
Conditions
Interventions
This is a two-arm, open-label, randomized controlled pilot trial that will be conducted with 40 women who are breast cancer survivors and have undergone unilateral or bilateral mastectomy. Prior to co
Sponsors
Faculdade de Filosofia, Ciências e Letras de Ribeirão Preto da Universidade de São Paulo
Faculdade de Filosofia, Ciências e Letras de Ribeirão Preto da Universidade de São Paulo
Eligibility
Sex/Gender
Female
Age
20 Years to 59 Years
Inclusion criteria
Inclusion criteria: Female breast cancer survivors; undergone unilateral or bilateral mastectomy; aged between 20 and 59 years
Exclusion criteria
Exclusion criteria: Pregnant; breastfeeding; history of metastasis; presence of a medical condition that affects physical appearance, such as AIDS; diagnosis of autoimmune diseases; severe burns; outside the established age range; incomplete primary education
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to assess the feasibility of conducting a randomized controlled trial, as determined by recruitment, retention, and intervention adherence rates.The retention rate will be calculated as the ratio of the number of participants who complete the study to the total number of participants randomized, multiplied by 100. A retention rate of at least 50% at the end of the follow-up is expected, based on a previous feasibility study and the literature. The recruitment rate will be calculated as the ratio of the number of participants who initiate the intervention to the total number of individuals screened, multiplied by 100. No a priori threshold will be established, and the results will be used to estimate recruitment feasibility for a future study. Adherence to the intervention will be assessed based on the percentage of sessions attended and the level of participation in the proposed activities. Participants will be considered adherent if they attend at least 60% of the sessions, a threshold defined based on a previous study with a similar population that demonstrated moderate intervention completion rates. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to evaluate changes in body appreciation, functionality appreciation, and self-compassion, as measured by validated instruments administered at pre-intervention, post-intervention, and follow-up, expecting to observe variations in mean scores across the different assessment time points, estimated using measures of central tendency and dispersion, such as mean and standard deviation, in order to inform the sample size calculation for a future study. | — |
Countries
BR
Contacts
Public ContactKeila Avelar
Universidade de São Paulo
Outcome results
None listed