Effect of Family-Centered Empowerment Model on Cancer-stigma in patients with cancer

Determining the impact of family-centered empowerment model on cancer stigma in cancer patients

Study will be conducted as a clinical trial with two groups: a control and an intervention group, using a single-blind method, with random allocation through the use of sealed envelopes on 80 patients.

This study will be conducted in the hematology department or the outpatient chemotherapy center of Ayatollah Rouhani Hospital in Babol. 40 patients will be placed in each group. The questionnaire related to cancer stigma will initially be completed by both groups. Then, one month after the implementation of family-center empowerment model through virtual environment in the intervention group, and one month after the pre-test in the control group, the questionnaire will be completed again by the patients.

Registering the diagnosis of cancer related to the digestive, blood circulation and urogenital system, at least 6 months have passed since the diagnosis, the patient is over 18 years old and the caregiver is between 18 and 60 years old, lack of previous care history of a cancer patient by the caregiver, ability to use virtual environment Failure to enter: Suffering from mental problems and learning disorders, unwillingness to attend the meetings, are among health care providers

In this study, the control and intervention group will receive routine cancer care. In the intervention group, the patient and their family caregiver will undergo family-centered empowerment model in four main steps, which include: Understanding the threat, Enhancing self-efficacy/problem-solving, Promoting self-belief and self-esteem through educational participation, Evaluation.

Cancer stigma

Individuals are selected through convenience sampling and are randomly divided into two groups: control and intervention. To achieve randomization, a method of drawing sealed envelopes is used. In this method, a number of envelopes are designated by the researcher for the intervention group, and the same number of envelopes is allocated for the control group. Then, by merging the envelopes together (drawing the envelopes), one envelope is drawn and its allocation is recorded. After being drawn, that envelope is returned to the collection of other envelopes. Then the letters are merged again, and another letter is produced. This process continues until a random sequence corresponding to the sample size is reached. The concealment of random allocation is also carried out using opaque envelopes that are sealed with a random sequence. In this method, a random sequence is first generated using the mentioned method. Then, based on the sample size of the research, a number of letters are prepared with aluminum envelopes (to ensure the content of the letters is not visible), and each of the generated random sequences is recorded on one letter. The letters are then placed in the envelopes in order. In order to maintain a random sequence, the envelopes are numbered on the outside in the same order. Finally, the flaps of the envelopes are sealed and placed in a box in order. At the time of starting the registration of participants, based on the order of arrival of eligible participants for the study, one of the envelopes is opened in sequence, revealing the assigned group of that participant. The intervention and control groups are matched based on the average ratio of gender and age.

In this study, a single-blind method will be used for the patients. In this way, for the intervention group, in addition to providing routine care, family-centered empowerment model will be conducted for the patient and their family caregiver, while the control group will only receive routine cancer-related care. It is worth mentioning that none of the participants will be aware of which group they belong to.

After the end of the study and data analysis, the results and data including study protocol, statistical analysis map, clinical study report after removing confidential information will be available to all people who want to access and use this study

Beginning of the access period from 2026

All people

Access is free

Applicants can receive documents through the email address elhamegzb75@gmail.com.

Applicants should proceed with a full explanation of the purpose of accessing data and documents through a signed and official letter. Approximate time to send documents is 2 weeks.